The FDIC is issuing a final rule (“Final Rule”) that treats a mutual insurance holding company as an insurance company for purposes of Section 203(e) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”). The Final Rule clarifies that the liquidation and rehabilitation of a covered financial company that is a mutual insurance holding company will be conducted in the same manner as an insurance company. The Final Rule harmonizes the treatment of mutual insurance holding companies under Section 203(e) of the Dodd-Frank Act with the treatment of such companies under state insurance company insolvency laws.

Title II of the Dodd-Frank Act provides for the appointment of the FDIC as receiver of a nonviable financial company that poses significant risk to the financial stability of the United States (a “covered financial company”), outlines the process for the orderly liquidation of a covered financial company following the FDIC's appointment as receiver and provides for additional implementation of the orderly liquidation authority by rulemaking. The Final Rule is promulgated pursuant to Section 2091of the Dodd-Frank Act, which authorizes the FDIC, in consultation with the Financial Stability Oversight Council, to prescribe such rules and regulations as the FDIC considers necessary or appropriate to implement Title II. Section 209 of the Dodd-Frank Act further provides that, to the extent possible, the FDIC should seek to harmonize rules and regulations promulgated under Section 209 with the insolvency laws that would otherwise apply to a covered financial company.

112 U.S.C. 5389.

On December 13, 2011, the FDIC published a Notice of Proposed Rulemaking (“NPR”) in theFederal Register2setting forth the conditions under which a mutual insurance holding company would be resolved as an insurance company under Section 203(e) of the Dodd-Frank Act. The comment period for the NPR closed on February 13, 2012, and the FDIC received four comment letters. Additionally, the FDIC held a conference call with representatives of the National Association of Insurance Commissioners on January 17, 2012 and received their comments on the NPR.

276 FR 77442 (December 13, 2011).

In light of the comments received and pursuant to the authority granted to it by Section 209 of the Dodd-Frank Act, the FDIC is issuing the Final Rule.

History of Mutual Insurance Holding Company

The mutual insurance industry traces its roots back to England, where, in 1696, the first mutual fire insurer was established. The first American mutual insurance company, the Philadelphia Contributionship for the Insurance of Houses from Loss by Fire, was founded in 1752.3

Mutual insurance companies have no equity interests. Membership rights are held by their policyholders. Policyholders are entitled to vote for members of the company's board of directors and may receive special dividends in the form of capital distributions or reductions of policy premiums.

The mutual insurance holding company structure was first created in Iowa in 1995.4A mutual insurance holding company is created through the restructuring of a mutual insurance company into two entities, a mutual insurance holding company and a stock insurance company that is converted from the original mutual insurance company. In a variation of this restructuring, a third entity may be formed, an intermediate insurance stock holding company. In this three-entity structure, in most instances, the mutual insurance holding company initially owns 100% of the intermediate insurance stock holding company, and the intermediate insurance stock holding company initially owns 100% of the stock of the converted mutual insurance company. The purpose of the restructuring is to preserve the benefits of a mutual form of organization while allowing the converted mutual insurance company access to capital markets either through sale of its stock or, in a three-entity structure, the sale of the stock of the intermediate insurance stock holding company.

4Iowa Code Ann. (West) § 521A.14.

Consistent with the mutual insurance company, a mutual insurance holding company also has no equity interests. Membership rights are held by the policyholders of the converted mutual insurance company who have rights similar to those they had as policyholders of the mutual insurance company before conversion. Policyholders of the converted mutual insurance company are entitled to vote for members of the mutual insurance holding company's board of directors, and may receive special dividends in the form of capital distributions or reductions of policy premiums.

A majority of the states have adopted statutes providing for the formation of mutual insurance holding companies. Those statutes generally (a) provide for the regulation of a mutual insurance holding company at the holding company level by the insurance commissioner of the domiciliary state; (b) require that the mutual insuranceholding company maintain voting control over the converted mutual insurance company; and (c) specifically subject a mutual insurance holding company to liquidation or rehabilitation under the state regime if the converted mutual insurance company is placed in liquidation or rehabilitation. In addition, either by statute, rule or regulation, in the liquidation of a converted mutual insurance company, the assets of the mutual insurance holding company generally are included in the estate of the converted mutual insurance company being liquidated.5

Treatment of an Insurance Company Under Section 203(e) of the Dodd-Frank Act

In providing for the orderly liquidation of a covered financial company under Title II of the Dodd-Frank Act, Congress recognized that insurance companies historically had been liquidated and rehabilitated pursuant to a state insolvency framework. As a result, Congress provided that “if an insurance company is a covered financial company or a subsidiary or affiliate of a covered financial company, the liquidation or rehabilitation of such insurance company, and any subsidiary or affiliate of such company that is [an insurance company], shall be conducted as provided under applicable State law.”6

612 U.S.C. 5383(e)(1).

The term “insurance company” is defined in Section 201(a)(13) of the Dodd-Frank Act to mean “any entity that is—(A) engaged in the business of insurance; (B) subject to regulation by a State insurance regulator; and (C) covered by a State law that is designed to specifically deal with the rehabilitation, liquidation, or insolvency of an insurance company.”7The identical definition is found in Section 380.1 of Title 12 of the Code of Federal Regulations. Concerns have been raised with respect to the application of this definition to mutual insurance holding companies because, under applicable state laws, a mutual insurance holding company generally is prohibited from selling policies of insurance. Thus, a mutual insurance holding company arguably does not fit squarely within a literal reading of the statutory definition of insurance company under the Dodd-Frank Act.

712 U.S.C. 5381(a)(13).

The treatment of a mutual insurance holding company, under certain circumstances, as an insurance company for purposes of Section 203(e) is consistent with the legislative intent of the Dodd-Frank Act.8This treatment is appropriate given the legal structure that forms a mutual insurance holding company from a converted mutual insurance company and the continuing interest of the policyholders of the converted mutual insurance company in both the converted mutual insurance company, as its customers, and the mutual insurance holding company, as holders of its membership interests. From a regulatory policy perspective, the extensive regulation of the mutual insurance holding company by the insurance commissioner of its domiciliary state and the inclusion of the mutual insurance holding company and its assets in the liquidation of the converted mutual insurance company also support this treatment.

8There is support in the legislative history of the Dodd-Frank Act for interpreting the term “insurance company” under Section 201(a)(13) to include a mutual insurance holding company.Seestatement of Rep. Barney Frank, 111 Cong. Rec. H5216 (daily ed. June 30, 2010) and statement of Sen. Christopher Dodd, 111 Cong. Rec. S5903 (daily ed. July 15, 2010).

II. Notice of Proposed Rulemaking: Summary of Comments

On December 13, 2011, the FDIC invited public comment on a Notice of Proposed Rulemaking: Mutual Insurance Holding Company Treated as Insurance Company (the “Proposed Rule”).9The comment period ended on February 13, 2012. The FDIC received four comment letters from several industry and trade organizations representing the insurance industry and one individual. In addition, the FDIC met with representatives of the National Association of Insurance Commissioners to discuss the Proposed Rule.

976 FR 77442 (December 13, 2011).

The Proposed Rule clarified that a mutual insurance holding company would be treated in the same manner applicable to insurance companies under Section 203(e) of the Dodd-Frank Act, which provides that “if an insurance company is a covered financial company or a subsidiary or affiliate of a covered financial company, the liquidation or rehabilitation of such insurance company, and any subsidiary or affiliate of such company that is [an insurance company], shall be conducted as provided under applicable State law.”10This proposed treatment was limited to mutual insurance holding companies whose largest United States subsidiary (as measured by total assets as of the end of the previous calendar quarter) is an insurance company or an intermediate insurance stock holding company, and whose investments are limited to the securities of an intermediate insurance stock holding company, the securities of the converted mutual insurance company and other assets and securities of the type authorized for holding and investment by an insurance company domiciled in its state of incorporation. The Proposed Rule also provided that this treatment apply only to mutual insurance holding companies that are regulated by and are subject to the insurance company insolvency laws of their states of domicile, and that are not subject to bankruptcy proceedings.

1012 U.S.C. 5383(e)(1).

The public comments supported the Proposed Rule's objective of treating a mutual insurance holding company as an insurance company for purposes of Section 203(e) of the Dodd-Frank Act.11The comments focused on two elements of the Proposed Rule: The definitions of mutual insurance holding company and intermediate insurance stock holding company and the conditions imposed in order for a mutual insurance holding company to qualify as an insurance company under Section 203(e) of the Dodd-Frank Act.

1112 U.S.C. 5383(e).

Most of the commenters suggested that the definition of mutual insurance holding company be modified with respect to the requirement that the mutual insurance holding company “hold either (i) At least 51% of the issued and outstanding voting stock of the intermediate insurance stock holding company, if any, or (ii) if there is no intermediate insurance stock holding company, at least 51% of the issued and outstanding voting stock of the converted mutual insurance company.” Several commenters noted that many state laws only require the mutual insurance holding company to own a majority of the voting stock of the intermediate insurance stock holding company, if any, or, if there is no intermediate insurance stock holding company, a majority of the voting stock of the converted mutual insurance company. One commenter recommended substituting “a majority of the voting stock” for “51% of the issued and outstanding voting stock” where the phrase appears within the definition of mutual insurance holding company. Another commenter recommended substituting “a majority of the voting power in the election of directors” for “51% of the issued and outstanding voting stock” where the phrase appears within the definition of mutual insurance holding company.

Several commenters suggested that the definition of intermediate insurance stock holding company be modified with respect to the requirement that the intermediate insurance stock holding company “hold all of the issued and outstanding voting stock of the converted mutual insurance company.” One commenter suggested that the word “all” be changed to “a majority” to be more consistent with the requirements of state law. Another commenter suggested retaining the concept of “all of the issued and outstanding voting stock” but allow the ownership to be “directly or indirectly.”

One commenter suggested that the definition of intermediate insurance stock holding company be modified to clarify that an intermediate insurance stock holding company can be formed either at the time of or at any time after the conversion of the mutual insurance company into a stock insurance company. Another commenter suggested deleting the phrase “For purposes of this subpart” from the definition of intermediate insurance stock holding company to be consistent with other definitions in § 380.1.

Several commenters suggested that the definition of mutual insurance company be modified. One commenter suggested that the word “association” should be changed to “corporation” because a mutual insurance company is a non-stock corporation and not an association. The same commenter suggested changing the words “in which equity and voting rights are vested in the policyholders” to “in which rights in surplus and membership interests are vested in the policyholders” because a mutual insurance company has “surplus” not “equity” and the interests of the members may be broader than just voting rights. Another commenter suggested changing the words “in which equity and voting rights are vested in the policyholders” to “in which equity, voting rights and control are vested in the policyholders” to emphasize that “policyholders actually exercise effective control, rather than have that power merely conferred by charter or otherwise.” One commenter suggested deleting the word “domestic” in the phrase “a domestic insurance company organized under the laws of a State” because it was redundant.

With respect to the conditions that must exist for a mutual insurance holding company to be treated as an insurance company for the purpose of Section 203(e) of the Dodd-Frank Act as set forth in § 380.11, several commenters suggested modifying one or more of the conditions. One commenter suggested removing the condition that the company is not subject to bankruptcy proceedings under Title 11 of the United States Code, i.e., the U.S. Bankruptcy Code. The commenter noted that the issue of whether a mutual insurance holding company is excluded from coverage under the U.S. Bankruptcy Code is unsettled. Thus, in the commenter's view, imposing the condition in § 380.11 introduced uncertainty about whether a mutual insurance holding company would be treated as an insurance company for the purpose of Section 203(e) of the Dodd-Frank Act.

Several commenters suggested modifying the requirement in § 380.11 that the mutual insurance holding company limit its assets and investments to the securities of an intermediate insurance stock holding company, the securities of the converted mutual insurance company “and other assets and securities of the type authorized for holding and investment by an insurance company domiciled in its state of incorporation.” The commenters noted that the requirement is not mandated by state law although some states do limit a mutual insurance holding company's investment in non-insurance assets. One of those commenters suggested that the mutual insurance holding company be allowed to make any investment “permitted under applicable State law.”

The FDIC has carefully considered the comments and made appropriate revisions to the Final Rule as described below.

III. Description of Final RuleA. Overview

The Final Rule modifies Part 380 of Title 12 of the Code of Federal Regulations, and provides generally that a mutual insurance holding company that meets the requirements of the Final Rule will be treated as an insurance company for the purpose of Section 203(e) of the Dodd-Frank Act.

B. Section-by-Section Analysis of the Final Rule

The Final Rule adds three definitions to Section 380.1 of Title 12 of the Code of Federal Regulations: Intermediate insurance stock holding company; mutual insurance company; and mutual insurance holding company. The definition of mutual insurance holding company has been modified in the Final Rule to provide that the company could own a “majority” of the stock of the intermediate insurance stock holding company and the converted mutual insurance company instead of the specific threshold of “at least 51%” included in the Proposed Rule. The definition of the intermediate insurance stock holding company was also modified in the Final Rule to delete an unnecessary introductory phrase “For purposes of this subpart” and to indicate that such company could be organized either at the time of or after the organization of the mutual insurance holding company and could hold “a majority” rather than “all” of the stock of the converted mutual insurance company. In addition, the definition of the mutual insurance company was amended to reflect that it is organized as a non-stock mutual corporation, not an association, and that its policyholders hold the surplus, not “equity” in this company. The Final Rule does not include any additional changes suggested by the public comments to permit the mutual insurance holding company to hold the voting stock of the intermediate insurance stock holding company directly or indirectly or to permit the intermediate insurance stock holding company to hold the voting stock of the converted mutual insurance company directly or indirectly. These changes appear inconsistent with the existing mutual insurance holding company structure. Likewise, the Final Rule does not remove the term “voting rights” and substitute the term “membership interests” since voting rights remain essential to defining the control of the mutual insurance company and the intermediate insurance stock holding company.

The Final Rule adds Section 380.11 to provide that a mutual insurance holding company shall be treated as an insurance company for the purpose of Section 203(e) of the Dodd-Frank Act, 12 U.S.C. 5383(e); provided that: (a) It is subject to the insurance laws of the state of its domicile, including specifically and without limitation, a statutory regime for the rehabilitation or liquidation of insurance companies that are in default or in danger of default; (b) it is not subject to bankruptcy proceedings under Title 11 of the United States Code; (c) its largest United States subsidiary (as measured by total assets as of the end of the previous calendar quarter) is an insurance company or an intermediate insurance stock holding company; and (d) its investments are limited to the securities of an intermediate insurance stock holding company, the securities of the converted mutual insurance company and other assets and securities of the type authorized for holding and investment by an insurance company domiciled in its state of incorporation.

The first proviso requires that the mutual insurance holding company be subject to the insurance laws of the state of its domicile, including specifically and without limitation, a statutory regime for the rehabilitation or liquidation of insurance companies that are in default or in danger of default and is included in the Final Rule to be consistent with two of the three prongs of the definition of “insurance company” set forth in Section 201(a)(13) of the Dodd-Frank Act. The reference to companies that are “in default or in danger of default” ensures that the state resolution process will be applicable in a time and manner comparable to the Title II orderly liquidation process, which applies to financial companies that are in default or in danger of default under Section 203(b)(1) of the Dodd-Frank Act.

The second proviso requires that the mutual insurance holding company is not subject to bankruptcy proceedings under Title 11 of the United States Code and is included to make clear that the mutual insurance holding company must not only be subject to the applicable state insurance law but must also be resolved under the applicable state insurance law. Thus, the Final Rule does not delete this requirement as some public comments suggested, but rather retains it to ensure that there is no ambiguity or conflict with respect to the determination of which insolvency regime is applicable to a mutual insurance holding company. To the extent that any such ambiguity or conflict exists, it is the intent of the Final Rule that the ambiguity be resolved in favor of allowing resolution under Title II of the Dodd-Frank Act even if the mutual insurance holding company may be an eligible debtor under Title 11 of the United States Code.

The third proviso, which requires that the mutual insurance holding company's largest United States subsidiary (as measured by total assets as of the end of the previous calendar quarter) is an insurance company or an intermediate insurance stock holding company, is included to ensure that, if a mutual insurance holding company covered by the Final Rule is placed in orderly liquidation under Title II of the Dodd-Frank Act, the Director of the Federal Insurance Office would participate in making the recommendation to take such action in accordance with the provisions of Section 203(a)(1)(C) of the Dodd-Frank Act. In addition, this requirement is intended to make clear that an insurance company subsidiary of the mutual insurance holding company must be its most significant subsidiary by asset size.

The final proviso requires the mutual insurance holding company to limit its investments to the securities of the intermediate insurance stock holding company, the securities of the converted mutual insurance company and other assets and securities of the type authorized for holding and investment by an insurance company domiciled in its state of incorporation. The FDIC rejected a public comment to alter these investment requirements because the FDIC believes that this proviso ensures that the mutual insurance holding company is operating purely as a holding company and is not itself actively engaged in operating non-insurance businesses.12

12The investments of the intermediate insurance stock holding company, however, are not restricted in this manner because, under the Final Rule, the intermediate insurance stock holding company is not treated as an insurance company for the purpose of Section 203(e) of the Dodd-Frank Act.

IV. Regulatory Analysis and ProcedureA. Paperwork Reduction Act

In accordance with the Paperwork Reduction Act (44 U.S.C. 3501et seq.) (“PRA”), the FDIC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. The Final Rule would not involve any new collections of information pursuant to the Paperwork Reduction Act (44 U.S.C. 3501et seq.). Consequently, no information will be submitted to the Office of Management and Budget for review.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act 5 U.S.C. 601et seq.(RFA) requires each federal agency to prepare a final regulatory flexibility analysis in connection with the promulgation of a final rule, or certify that the final rule will not have a significant economic impact on a substantial number of small entities.13Pursuant to Section 605(b) of the Regulatory Flexibility Act, the FDIC certifies that the Final Rule will not have a significant economic impact on a substantial number of small entities.

13See 5 U.S.C. 603, 604 and 605.

Under regulations issued by the Small Business Administration (“SBA”), a “small entity” includes those firms within the “Finance and Insurance” sector with asset sizes that vary from $7 million or less in assets to $175 million or less in assets.14The Final Rule clarifies that a mutual insurance holding company that is a covered financial company will be treated as an insurance company for the purpose of Section 203(e) of the Dodd-Frank Act. The Final Rule provides internal guidance to FDIC personnel in such an event and will address an uncertainty in the financial system as to how such a company would be treated for purposes of Section 203(e) of the Dodd-Frank Act. For a mutual insurance holding company to be determined to be a covered financial company under Section 203(b) of the Dodd-Frank Act, its failure must have serious adverse effects on the financial stability of the United States. The Final Rule would apply to a mutual insurance holding company regardless of such company's size. Although the asset size of a company may not be the determinative factor of whether such company may pose a systemic risk to the financial stability of the United States, it is an important consideration. It is unlikely that the failure of a mutual insurance holding company that is at or below the $175 million asset threshold, or the nature, scope, size, scale, concentration, interconnectedness, or mix of its activities, would pose a threat to the financial stability of the United States. As such, the Final Rule will not have a significant economic impact on small entities.

1413 CFR 121.201.

C. Small Business Regulatory Enforcement Fairness Act

The Office of Management and Budget has determined that the Final Rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”) (5 U.S.C. 801et seq.).As required by SBREFA, the FDIC will file the appropriate reports with Congress and the General Accounting Office so that the Final Rule may be reviewed.

D. The Treasury and General Government Appropriations Act, 1999—Assessment of Federal Regulations and Policies on Families

The FDIC has determined that the Final Rule will not affect family well-being within the meaning of Section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681).

E. Plain Language

Section 722 of the Gramm-Leach-Bliley Act (Pub. L. 106-102, 113 Stat. 1338, 1471), requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. TheFDIC has sought to present the Final Rule in a simple and straightforward manner.

Intermediate insurance stock holding company.The term “intermediate insurance stock holding company” means a corporation organized either at the time of, or at any time after, the organization of the mutual insurance holding company that:

(1) Is a subsidiary of a mutual insurance holding company;

(2) Holds a majority of the issued and outstanding voting stock of the converted mutual insurance company created at the time of formation of the mutual insurance holding company; and

(3) Holds, as its largest United States subsidiary (as measured by total assets as of the end of the previous calendar quarter), an insurance company.

Mutual insurance company.The term “mutual insurance company”means an insurance company organized under the laws of a State that provides for the formation of such an entity as a non-stock mutual corporation in which the surplus and voting rights are vested in the policyholders.

(1) Is lawfully organized under state law authorizing its formation in connection with the reorganization of a mutual insurance company that converts the mutual insurance company to a stock insurance company, and—

(2) Holds either:

(i) A majority of the issued and outstanding voting stock of the intermediate insurance stock holding company, if any, or

(ii) If there is no intermediate insurance stock holding company, a majority of the issued and outstanding voting stock of the converted mutual insurance company.

A mutual insurance holding company shall be treated as an insurance company for the purpose of section 203(e) of the Dodd-Frank Act, 12 U.S.C. 5383(e); provided that—

(a) The company is subject to the insurance laws of the state of its domicile, including, specifically and without limitation, a statutory regime for the rehabilitation or liquidation of insurance companies that are in default or in danger of default;

(b) The company is not subject to bankruptcy proceedings under Title 11 of the United States Code;

(c) The largest United States subsidiary of the company (as measured by total assets as of the end of the previous calendar quarter) is an insurance company or an intermediate insurance stock holding company; and

(d) The assets and investments of the company are limited to the securities of an intermediate insurance stock holding company, the securities of the converted mutual insurance company and other assets and securities of the type authorized for holding and investment by an insurance company domiciled in its state of incorporation.

The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

In theFederal Registerof April 13, 2011 (76 FR 20575), FDA proposed to amend its regulations to expand the scope of clinical investigator disqualification (the April 2011 proposed rule). As discussed in greater detail in the preamble to the proposed rule (76 FR 20575 at 20576 to 20585), when disqualified by a Commissioner's decision under one part of the former regulations a clinical investigator continued to be eligible to receive other types of test articles and conductclinical investigations studying those other test articles.

The GAO, in its September 2009 final report on FDA's oversight of clinical investigators (Ref. 1), recognized FDA's regulatory limitations regarding clinical investigator disqualification. In its September 2009 final report, the GAO recommended, among other things, that FDA extend disqualification by a Commissioner's decision to include ineligibility to receive unapproved drugs, biologics, and medical devices. The GAO concluded that it is “critical for FDA to take action—and to have the authority to take action—to prevent clinical investigators * * * who engaged in serious misconduct from doing so again, whether in research that involves drugs, biologics, or devices” (Ref. 1, at page 42). Among other amended provisions, this final rule responds to that GAO report and prevents clinical investigators who are disqualified by a Commissioner's decision (whether related to drugs, biologics, devices, or animal drugs) from conducting any clinical investigations that support an application for a research or marketing permit for products regulated by FDA. The other amended provisions in this final rule provide for clarity and harmonization of the clinical investigator disqualification regulations and the addition of inadvertently omitted regulatory provisions under which a part 16 (21 CFR part 16) regulatory hearing is available.

II. Overview of the Final Rule

This final rule amends part 312 (21 CFR part 312) in § 312.70, part 511 (21 CFR part 511) in § 511.1(c), and part 812 (21 CFR part 812) in § 812.119) to provide that when the Commissioner determines that a clinical investigator is ineligible to receive the test article under that part (e.g., new animal drugs in part 511 or drugs in part 312), the clinical investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

Other amendments in this final rule, as explained in the preamble to the proposed rule, help to clarify and harmonize the clinical investigator disqualification regulations in parts 312, 511, and 812 (21 CFR part 812). Also, this final rule amends certain provisions in part 16 (21 CFR part 16) by:

• Adding to § 16.1(b)(2) an entry for § 812.119;

• Revising the entries for §§ 312.70 and 511.1(c)(1); and

• Adding to the list of regulatory provisions under which a part 16 regulatory hearing is available, provisions for:

On its own initiative, FDA modified the codified language published in the April 2011 proposed rule (76 FR 20575), to remove “pursuit of” from the proposed provisions in §§ 312.70(a), 511.1(c)(1), and 812.119(a). FDA made this change to clarify the rule and eliminate unnecessary language. In this final rule, therefore, the relevant language is “If an explanation is offered and accepted by the applicable Center, the Center will discontinue the disqualification proceeding” (see in this document codified §§ 312.70(a), 511.1(c)(1), and 812.119(a)).

This final rule helps to protect the rights and safety of subjects involved in FDA-regulated investigations, and helps to ensure the reliability and integrity of the data used to support marketing of products regulated by FDA.

III. Comments on the Proposed Rule

FDA received two comments on the proposed rule: One from a healthcare professional and the other from regulated industry. Both submissions supported the proposal to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. The healthcare professional supported the proposal and had no other comment. The following comments and responses summarize and address the issues found in the submission from regulated industry:

(Comment 1) The comment suggests that FDA either clarify or define the terms “repeatedly or deliberately” or alternatively consider removing the language from § 812.119(a). The comment further asks that FDA consider how much data or what frequency constitutes “repeatedly”; and for “deliberately”, how FDA proposes to determine deliberate actions. The comment requests examples.

(Response) The interpretations of the terms “repeatedly” and “deliberately” in FDA's regulations governing disqualification of clinical investigators are well established. The term “repeatedly” means, simply, more than once.1A violation occurs “repeatedly” if it happens more than once.2

1See, e.g., Commissioner's Decision, In the Matter of William H Ziering, M.D. (2008), at page 7. “The term `repeatedly,' as it is used in 21 CFR 312.70(b), is given its plain meaning, such that a clinical investigator may be found to have acted `repeatedly' if he or she engages in proscribed conduct `more than once.' ” (http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM144019.pdf).

FDA may consider disqualification if a clinical investigator commits a regulatory violation more than one time within a single study (e.g., enrolling in a single study two study subjects who were ineligible because of concomitant illnesses that put those subjects at greater risk) or one time in each of two studies (e.g., enrolling in each of two studies, a study subject who was ineligible because of a concomitant illness putting the subject at greater risk). The Commissioner, in past decisions, has determined that multiple violations within a single study constitute repeated violations sufficient to support disqualification from receipt of test articles.3

3See, e.g., Commissioner's Decision, In the Matter of James A. Halikas (2001), at page 23 (“[T]o interpret repeatedly to mean transgressions in more than one study would permit an investigator to commit as many violations of the regulations as he/she wished without possibility of disqualification as long as that investigator limited his/her violations to one study. Such a result * * * would be absurd.”) (http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm143242.htm). See also Commissioner's Decision, In the Matter of Layne O. Gentry (2008), at page 23. (http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143906.pdf).

The term “deliberately” includes conduct that is “willful” as well as conduct demonstrating reckless disregard.4Accordingly, when a clinical investigator knowingly fails to comply with FDA's regulations, the clinical investigator may be found to have deliberately violated the regulations. FDA could pursue the disqualification of a clinical investigator, for example, if the investigator changed a study's results by altering a data field on a case report form to include false data. Likewise, an investigator who shows areckless disregard for whether his or her conduct may result in a regulatory violation may be found to have deliberately violated the regulations.

Decisionmakers in part 16 proceedings have interpreted the term “deliberately” in § 312.70(b) as roughly synonymous with the “deliberate indifference” or “willful” standard of intent.5This standard does not require specific knowledge that behavior, such as submission of false data to a study sponsor, violates the law, but reckless disregard for what the regulations require. The Commissioner's decision In the Matter of Layne O. Gentry6provides a useful discussion of the standard for “deliberate” behavior in a disqualification proceeding:7

5See, e.g., Commissioner's Decision, In the Matter of William H Ziering, M.D. (2008), at page 8 (“A clinical investigator may be found to have acted `deliberately' * * * if he or she knowingly or willfully engaged in conduct that violates FDA's regulations or if the investigator engaged in conduct that demonstrated a reckless disregard for compliance with FDA's regulations.”) Seehttp://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM144019.pdf.

* * * the term “deliberate,” when used to describe a category of violations that might lead to legal consequences, does not necessarily require a showing of subjective intent on the part of the person in question. * * * the purpose of [disqualification] is to protect the safety of patients and to preserve the integrity of the data needed to assess the safety and effectiveness of drugs before being sold to the general public through disqualifying investigators who do not fulfill the responsibilities imposed on them.

In the context of such a remedial, as opposed to punitive, scheme, an objective standard for “deliberate” or “deliberately” is a better fit because the inquiry should focus on preventing risk rather than imposing punishment for culpable conduct. Even if the investigator did not intend for the violations to occur, conduct demonstrating a reckless disregard for the regulatory requirements calls into question the investigator's fitness for conducting clinical trials. * * *

Therefore, to sustain a finding of repeated or deliberate submission of false information, FDA must show that the clinical investigator repeatedly submitted to the sponsor or to FDA false information, whether in a single study or in multiple studies, or submitted false information to the sponsor or FDA knowingly or willfully or with reckless disregard for the truthfulness of the data submitted.

(Comment 2) The comment asks how far back FDA will investigate FDA-approved products with a disqualified investigator's data; and requests an explanation of how FDA handles products that have been on the market for a longer period of time without significant safety concerns.

(Response) FDA uses its best efforts to identify each application and submission to FDA that may include data from a disqualified clinical investigator. FDA does not place limits on how far back FDA will investigate to find those applications and submissions that may be affected by a disqualified investigator who conducted trials with FDA-regulated test articles.

Each application or submission identified as containing data reported by a disqualified investigator is subject to examination to determine whether the investigator has submitted unreliable data that are essential to the approval of a marketing application or essential to the continued marketing of an FDA-regulated product. (See §§ 312.70(c), 511.1(c)(3), and 812.119(c)). This examination may be undertaken by FDA or the study sponsor. If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued approval of the product for which the data were submitted cannot be justified, the Commissioner will proceed to rescind clearance or withdraw approval of the product in accordance with the applicable provisions of the relevant statutes. (See §§ 812.119(e), 511.1(c)(5), and 312.70(e)).

Often, there may be sufficient data from sources other than the disqualified investigator's data to support the continued approval of the product. Those products that have been on the market for a longer period of time without significant safety concerns, even though a disqualified investigator contributed to the data relied on for approval, would probably remain on the market if sufficient reliable product-approval data support the continued approval of the product.

(Response) FDA agrees that sponsors should be informed promptly about the disqualification of a clinical investigator. Indeed, FDA informs sponsors at several stages of the disqualification process. When FDA initiates a disqualification action, FDA sends to the clinical investigator a notice of initiation of disqualification proceedings and opportunity to explain (NIDPOE) letter. Following confirmed receipt of the NIDPOE letter by the clinical investigator, FDA provides a redacted copy of the letter to the study sponsor and reviewing institutional review boards (IRBs) (see Ref. 2, section II.C., at page 8), and posts the redacted NIDPOE letter on FDA's Web site.8The posted NIDPOE letter is intended to inform sponsors and others who may have an interest that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving test articles.

If the investigator's explanation is not accepted by FDA or if the investigator fails to respond to the NIDPOE letter within the specified time period, FDA offers the investigator an opportunity for an informal regulatory hearing under part 16 to determine whether the investigator should remain eligible to receive test articles. FDA initiates a part 16 hearing by sending to the investigator a Notice of Opportunity for Hearing (NOOH). The NOOH specifies the facts and other relevant information that are the subject of the part 16 hearing (see Ref. 2,id.). FDA posts on its Web site9the names of clinical investigators who have been issued a NOOH concerning a disqualification proceeding along with the redacted NOOH.

If the investigator is disqualified, after receiving confirmation that the investigator has been notified of his or her disqualification, FDA promptly posts on its Web site10the investigator's name and the date of the disqualification action. In addition, FDA notifies the study sponsor and reviewing IRBs, in writing, about the disqualification action (Ref. 2,id.). This notification provides a statement of the basis for the Commissioner's disqualification determination (see §§ 312.70(b), 511.1(c)(2), and 812.119(b)).

FDA recommends that sponsors routinely check FDA's compliance and enforcement Web sites11for information about investigator disqualification proceedings that might affect the sponsor's studies. Further, in compliance with a sponsor's responsibilities (see, e.g., §§ 312.53(a), 511.1(b)(7)(i), and 812.43(a)), a sponsor must select only investigators qualified by training and experience as appropriate experts to investigate the study. A sponsor therefore must performdue diligence to ensure that an investigator is eligible to receive the test article. FDA considers checking FDA's Web site for investigator disqualification to be part of a sponsor's due diligence effort before selecting a clinical investigator to conduct a sponsor's study.

(Comment 4) The comment recommends that FDA consider the impact of investigator disqualification on the submission of results from failed investigations to ClinicalTrials.gov.

(Response) The comment is beyond the scope of this rulemaking as the National Institutes of Health (NIH) has the statutory responsibility for implementing the provisions under the Public Health Service Act, section 402(j), 42 U.S.C. 282(j)—Expanded Clinical Trial Registry Data Bank. The NIH proposes to issue new regulations12that will prescribe procedures for registering and reporting the results of clinical trials at ClinicalTrials.gov in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. 110-85, September 27, 2007).

(Comment 5) The comment recommends that FDA seek input from affected sponsors regarding the impact of a clinical investigator's disqualification on the validity of clinical trial or marketed product data.

(Response) As discussed in response to Comment 2 in this document, upon disqualification of a clinical investigator, each application or submission to FDA containing data reported by a disqualified investigator is subject to examination (see §§ 312.70(c), 511.1(c)(3), and 812.119(c)). We agree that FDA may seek input from an affected study sponsor; for example, FDA may request from the study sponsor statistical analyses of study results after eliminating from the database the disqualified investigator's data.

(Comment 6) The comment asks FDA to clarify whether the rule applies to “all sponsors for whom the investigator did work, or only those that were subject to the problem that caused the disqualification.”

(Response) This final rule applies to all sponsors who selected the clinical investigator to conduct their studies. FDA will assess the reliability of any data developed by a disqualified clinical investigator.

(Comment 7) The comment recommends that, because clinical investigator disqualification by a Commissioner's decision is a lengthy proceeding, FDA consider instituting a process similar to a clinical hold “to prevent these individuals from continuing to conduct clinical trials while the disqualification process is underway.”

(Response) FDA agrees that the use of a clinical hold following clinical investigator misconduct may be appropriate in some situations and has issued a guidance document indicating this (see Ref. 3). For example, FDA may impose a clinical hold on studies where the hold is necessary to protect human subjects in the study from an unreasonable and significant risk of illness or injury. In such a case, FDA may impose a clinical hold based on credible evidence that a clinical investigator conducting the study has committed serious violations of FDA regulations on clinical trials of human drugs and biologics, including parts 312, 50, and 56 (21 CFR parts 50 and 56), or has submitted false information to FDA or the sponsor in any required report. Such a clinical hold may be imposed on the study in which the misconduct occurred or on other studies of drugs or biological products in which the clinical investigator is directly involved or proposed to be involved if FDA determines that the investigator's misconduct poses an ongoing threat to the safety and welfare of such subjects. (See §§ 312.42(b)(1)(i), 312.42(b)(2)(i), 312.42(b)(3)(iii), and 312.42(b)(4)(i)) (Ref. 3).

For medical devices, § 812.30(b) allows for withdrawal of approval of an application for an investigational device exemption (IDE). Under this provision, FDA may withdraw approval of an application if FDA determines that continuation of testing under an IDE will result in an unreasonable risk to subjects.

(Comment 8) The comment recommends that FDA issue guidance on how a disqualified investigator's data in applications and submissions to FDA is to be handled, segregated, analyzed, and reported.

(Response) Because each situation is different, FDA evaluates on a case-by-case basis the best course of action for handling a disqualified clinical investigator's data in applications and submissions. For this reason, FDA does not intend to issue guidance to address how a disqualified investigator's data should be handled.

(Comment 9) The comment recommends that FDA state explicitly in the rule that when an investigator is disqualified by FDA from studies of veterinary drugs the investigator should also be ineligible to participate in studies of veterinary biologics regulated by the U.S. Department of Agriculture (USDA) under Title 9 of the Code of Federal Regulations; and, likewise, that “USDA should codify a companion rule to state that investigators disqualified from participation in studies of goods regulated by FDA will also be disqualified from investigations of veterinary biologics.”

(Response) As stated in the preamble to the proposed rule, FDA may refer pertinent matters to another Federal, State, or local government agency for any action determined appropriate by that agency. Although FDA agrees that affected agencies should be aware of judicial proceedings and regulatory actions taken involving clinical investigators, FDA does not have authority to draft a companion rule to be administered by USDA.

(Comment 10) The comment recommends that FDA notify sponsors when a disqualified clinical investigator has been reinstated.

(Response) We agree that FDA should notify interested parties when a clinical investigator is reinstated as eligible to receive FDA-regulated test articles. Because FDA has no way of knowing who, in particular, may be interested in the reinstatement of a certain investigator, FDA lists on its Web site those investigators who have been reinstated.13

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Legal Authority

The purpose of disqualifying investigators who violate the regulations is to preserve the integrity of data needed to assess the safety and effectiveness of an FDA-regulated product before the product is made available to the public, and to protect the safety of study subjects during the conduct of a clinical investigation and patient safety after the approval or clearance of a marketing application.

Although the concept of disqualification is not explicitly mentioned in the FD&C Act, FDA hasthe authority to disqualify clinical investigators who violate FDA's regulations. The Supreme Court inWeinbergerv.Bentex Pharmaceuticals, Inc.,412 U.S. 645, 653 (1973) has recognized that FDA has authority that “is implicit in the regulatory scheme, not spelled out inhaec verba”in the statute. As stated inMorrowv.Clayton,326 F.2d 36, 44 (10th Cir. 1963): “[I]t is a fundamental principle of administrative law that the powers of an administrative agency are not limited to those expressly granted by the statutes, but include, also, all of the powers that may fairly be implied therefrom.”

“[R]egulatory acts should be given a practical construction, and one which will enable the agency to perform the duties required of it by Congress.”Federal Deposit Ins. Corp.v.Sumner Fin. Corp.,451 F.2d 898, 904 (5th Cir. 1971). Congressional inaction on proposed legislation that would state expressly an agency's authority to act does not support an inference that the agency lacks implicit authority to act under existing legislation.Red Lion Broadcasting Co.v.FCC,395 U.S. 367, 381-382 n. 11 (1969). See alsoLeistv.Simplot,638 F.2d 283, 318 (2d Cir. 1980),affirmed sub nom. Merrill Lynch, Pierce, Fenner & Smithv.Curran,456 U.S. 353 (1982). The Supreme Court has often recognized “the construction of a statute by those charged with its administration is entitled to substantial deference.”United Statesv.Rutherford,442 U.S. 544 (1979).Board of Governors of FRSv.First Lincolnwood,439 U.S. 234, 248 (1978) (the Court's conclusion “is influenced by the principle that courts should defer to an agency's construction of its own statutory mandate,Red Lion Broadcasting Co.v.FCC,395 U.S. at 381;Commissionerv.Sternberger's Estate,348 U.S. 187, 199 (1955), particularly when that construction accords with well established congressional goals.” 439 U.S. at 251);Bayside Enterprises, Inc.v.NLRB,429 U.S. 298, 304 (1977);Udallv.Tallman,380 U.S. 1, 16 (1965).

Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), the Commissioner is empowered to issue regulations for the efficient enforcement of the FD&C Act. Regulations issued by the Commissioner under section 701(a) of the FD&C Act for determining whether a clinical investigation of a drug intended for human use, among other things, was scientifically reliable and valid to support approval of a new drug, have been upheld by the Supreme Court (Weinbergerv.Hynson, Westcott & Dunning, Inc.); see alsoUpjohn Co.v.Finch,422 F.2d 944 (6th Cir. 1970); andPharmaceutical Manufacturers Associationv.Richardson,318 F.Supp. 301 (D.Del. 1970)).

Furthermore, sections 505(i), 512(j) and 520(g) of the FD&C Act (21 U.S.C. 355(i), 360b(j), and 360j(g)) regarding clinical investigations that require prior FDA authorization direct the Commissioner to issue regulations to protect the public health in the course of those investigations. Also, sections 505(i)(1), 512(j), and 520(g)(2)(A) of the FD&C Act require that investigations be conducted by “experts qualified by scientific training and experience.” An investigator who repeatedly or deliberately violates the regulations or who repeatedly or deliberately submits false information would not be considered a qualified expert with the experience required to conduct investigations of FDA-regulated articles. Among other stated objectives, the final rulemaking is intended to fulfill those mandates.

The Commissioner therefore concludes that legal authority to issue those regulations regarding clinical investigators exists under sections 505(i), 512(j), 520(g) and 701(a) of the FD&C Act, as essential to protection of the public health and safety and to enforcement of the Agency's responsibilities under sections 409, 502, 503, 505, 506, 510, 512, 513, 514, 515, 518, 519, 520 and 801 of the FD&C Act (21 U.S.C. 348, 352, 353, 355, 356, 360, 360b, 360c, 360d, 360e, 360h, 360i, 360j and 381), as well as the responsibilities of FDA under section 351 of the Public Health Service Act (42 U.S.C. 262).

VI. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). In accordance with Executive Order 12866, FDA has previously analyzed the potential economic effects of this final rule. As announced in the proposal, the Agency has determined that the rule is not a significant regulatory action as defined by Executive Order 12866. The Agency has not received any new information or comments that would alter its previous determination.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule does not impose new requirements on any entity and therefore has no associated compliance costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

Synopsis

This rule expands the scope of FDA's disqualification actions so that a disqualified clinical investigator is ineligible to receive any FDA-regulated test article and ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. We estimate that there is an average of about one matter per year in which clinical investigators are ultimately disqualified via a Commissioner's decision, and we do not expect that this final rule will impose additional costs. Non-quantifiable benefits of this final rule would include helping to reduce the risk of additional violations in other FDA-regulated investigations and helping to ensure the integrity ofclinical trial data. This final rule will help to reduce the risk to human subjects who participate in FDA-regulated investigations, and may lead to improved public confidence in the clinical data supporting FDA decisions. The full analysis of impacts is presented in Ref. 4 of this document.

VII. Paperwork Reduction Act of 1995

This final rule contains no new collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The information collection in § 312.70 pertaining to the disqualification of a clinical investigator and an investigator's opportunity to respond to FDA is approved under the investigational new drug regulations, OMB Control No. 0910-0014; expiration date February 28, 2013.14The notification of IRBs in § 312.70 is approved under OMB Control No. 0910-0130—Protection of Human Subjects; Recordkeeping Requirements for Institutional Review Boards (IRBs); expiration date April 30, 2014.15The information collection in § 511.1(c) pertaining to the disqualification of a clinical investigator and an investigator's opportunity to respond to FDA is approved under the new animal drugs for investigational use regulations OMB Control No. 0910-0117; expiration date August 31, 2011 (renewal pending at OMB).16The information collection in § 812.119 pertaining to the disqualification of a clinical investigator and an investigator's opportunity to respond to FDA is approved under the investigational device exemptions reports and records in 21 CFR part 812, OMB Control No. 0910-0078; expiration date February 28, 2013.17In addition, INDs and new drug applications are approved under OMB control number 0910-0416; animal drug applications, 21 CFR part 514, are approved under OMB control number 0910-0032; premarket notification submissions 510(k), subpart E, are approved under OMB control number 0910-0120; and premarket approvals of medical devices, 21 CFR part 814, are approved under OMB control number 0910-0231.

14Seehttp://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=200905-0910-005(accessed on March 30, 2012).

15Seehttp://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=200711-0910-003(accessed on March 30, 2012).

16Seehttp://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=200806-0910-005(accessed on March 30, 2012).

17Seehttp://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201001-0910-010(accessed on March 30, 2012).

VIII. Federalism

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

IX. References

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in theFederal Register.)

1. GAO Report to Congressional Requesters—Oversight of Clinical Investigators, Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators; GAO-09-807. Seehttp://www.gao.gov/new.items/d09807.pdf.2. See “Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions—Disqualification,” May 2010, athttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214008.pdf.3. See “Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct,” September 2004, athttp://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126997.pdf.4. Full Analysis of Impacts of Final Rule.List of Subjects21 CFR Part 16

2. Section 16.1 is amended in paragraph (b)(2) by numerically adding entries for “§ 58.204(b)”, “§ 812.119”, and “§ 822.7(a)(3)”, and by revising the entries for “§ 312.70” and “§ 511.1(c)(1)” to read as follows:§ 16.1Scope.

(b) * * *

(2) * * *

§ 58.204(b), relating to disqualifying a testing facility.

§ 312.70, relating to whether an investigator is eligible to receive test articles under part 312 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

§ 511.1(c)(1), relating to whether an investigator is eligible to receive test articles under part 511 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

§ 812.119, relating to whether an investigator is eligible to receive test articles under part 812 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

§ 822.7(a)(3), relating to an order to conduct postmarket surveillance of a medical device under section 522 of the act.

PART 312—INVESTIGATIONAL NEW DRUG APPLICATION3. The authority citation for 21 CFR part 312 continues to read as follows:Authority:

21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

4. Section 312.70 is revised to read as follows:§ 312.70Disqualification of a clinical investigator.

(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50 or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research will furnish the investigator written notice of the matter complained of and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered and accepted by the applicable Center, the Center will discontinue the disqualification proceeding. If an explanation is offered but not accepted by the applicable Center, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

(b) After evaluating all available information, including any explanation presented by the investigator, if the Commissioner determines that the investigator has repeatedly or deliberately failed to comply with the requirements of this part, part 50 or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Commissioner will notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing institutional review boards (IRBs) that the investigator is not eligible to receive test articles under this part. The notification to the investigator, sponsor, and IRBs will provide a statement of the basis for such determination. The notification also will explain that an investigator determined to be ineligible to receive test articles under this part will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

(c) Each application or submission to FDA under the provisions of this chapter containing data reported by an investigator who has been determined to be ineligible to receive FDA-regulated test articles is subject to examination to determine whether the investigator has submitted unreliable data that are essential to the continuation of an investigation or essential to the approval of a marketing application, or essential to the continued marketing of an FDA-regulated product.

(d) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the data remaining are inadequate to support a conclusion that it is reasonably safe to continue the investigation, the Commissioner will notify the sponsor, who shall have an opportunity for a regulatory hearing under part 16 of this chapter. If a danger to the public health exists, however, the Commissioner shall terminate the IND immediately and notify the sponsor and the reviewing IRBs of the termination. In such case, the sponsor shall have an opportunity for a regulatory hearing before FDA under part 16 on the question of whether the IND should be reinstated. The determination that an investigation may not be considered in support of a research or marketing application or a notification or petition submission does not, however, relieve the sponsor of any obligation under any other applicable regulation to submit to FDA the results of the investigation.

(e) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued approval of the product for which the data were submitted cannot be justified, the Commissioner will proceed to withdraw approval of the product in accordance with the applicable provisions of the relevant statutes.

(f) An investigator who has been determined to be ineligible under paragraph (b) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, solely in compliance with the applicable provisions of this chapter.

PART 511—NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE5. The authority citation for 21 CFR part 511 continues to read as follows:Authority:

§ 511.1New animal drugs for investigational use exempt from section 512(a) of the act.

(c)Disqualification of a clinical investigator.(1) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the conditions of these exempting regulations or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Center for Veterinary Medicine will furnish the investigator written notice of the matter complained of and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered and accepted by the Center for Veterinary Medicine, the Center will discontinue the disqualification proceeding. If an explanation is offered but not accepted by the Center for Veterinary Medicine, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on thequestion of whether the investigator is eligible to receive test articles under this part and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

(2) After evaluating all available information, including any explanation presented by the investigator, if the Commissioner determines that the investigator has repeatedly or deliberately failed to comply with the conditions of the exempting regulations in this subchapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Commissioner will notify the investigator and the sponsor of any investigation in which the investigator has been named as a participant that the investigator is not eligible to receive test articles under this part. The notification to the investigator and sponsor will provide a statement of the basis for such determination. The notification also will explain that an investigator determined to be ineligible to receive test articles under this part will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

(3) Each application or submission to FDA under the provisions of this chapter containing data reported by an investigator who has been determined to be ineligible to receive FDA-regulated test articles is subject to examination to determine whether the investigator has submitted unreliable data that are essential to the continuation of an investigation or essential to the approval of a marketing application, or essential to the continued marketing of an FDA-regulated product.

(4) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the data remaining are inadequate to support a conclusion that it is reasonably safe to continue the investigation, the Commissioner will notify the sponsor, who shall have an opportunity for a regulatory hearing under part 16 of this chapter. If a danger to the public health exists, however, the Commissioner shall terminate the exemption immediately and notify the sponsor of the termination. In such case, the sponsor shall have an opportunity for a regulatory hearing before FDA under part 16 on the question of whether the exemption should be reinstated. The determination that an investigation may not be considered in support of a research or marketing application or a notification or petition submission does not, however, relieve the sponsor of any obligation under any other applicable regulation to submit to FDA the results of the investigation.

(5) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued approval of the product for which the data were submitted cannot be justified, the Commissioner will proceed to withdraw approval of the product in accordance with the applicable provisions of the relevant statutes.

(6) An investigator who has been determined to be ineligible under paragraph (c)(2) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, solely in compliance with the applicable provisions of this chapter.

7. Section 511.3 is added to read as follows:§ 511.3Definitions.

As used in this part:

Contract research organizationmeans a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration.

Investigatormeans an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Subinvestigator” includes any other individual member of that team.

Sponsormeans a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

Sponsor-Investigatormeans an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.

PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS8. The authority citation for 21 CFR part 812 continues to read as follows:Authority:

9. Section 812.119 is revised to read as follows:§ 812.119Disqualification of a clinical investigator.

(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50, or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and Research will furnish the investigator written notice of the matter complained of and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered and accepted by the applicable Center, the Center will discontinue the disqualification proceeding. If an explanation is offered but not accepted by the applicable Center, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA.

(b) After evaluating all available information, including any explanation presented by the investigator, if the Commissioner determines that the investigator has repeatedly or deliberately failed to comply with therequirements of this part, part 50, or part 56 of this chapter, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report, the Commissioner will notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing investigational review boards (IRBs) that the investigator is not eligible to receive test articles under this part. The notification to the investigator, sponsor and IRBs will provide a statement of the basis for such determination. The notification also will explain that an investigator determined to be ineligible to receive test articles under this part will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.

(c) Each application or submission to FDA under the provisions of this chapter containing data reported by an investigator who has been determined to be ineligible to receive FDA-regulated test articles is subject to examination to determine whether the investigator has submitted unreliable data that are essential to the continuation of an investigation or essential to the clearance or approval of a marketing application, or essential to the continued marketing of an FDA-regulated product.

(d) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the data remaining are inadequate to support a conclusion that it is reasonably safe to continue the investigation, the Commissioner will notify the sponsor, who shall have an opportunity for a regulatory hearing under part 16 of this chapter. If a danger to the public health exists, however, the Commissioner shall terminate the investigational device exemption (IDE) immediately and notify the sponsor and the reviewing IRBs of the termination. In such case, the sponsor shall have an opportunity for a regulatory hearing before FDA under part 16 of this chapter on the question of whether the IDE should be reinstated. The determination that an investigation may not be considered in support of a research or marketing application or a notification or petition submission does not, however, relieve the sponsor of any obligation under any other applicable regulation to submit to FDA the results of the investigation.

(e) If the Commissioner determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued clearance or approval of the product for which the data were submitted cannot be justified, the Commissioner will proceed to rescind clearance or withdraw approval of the product in accordance with the applicable provisions of the relevant statutes.

(f) An investigator who has been determined to be ineligible under paragraph (b) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, solely in compliance with the applicable provisions of this chapter.

The Coast Guard will enforce the Navy Pier Southeast Safety Zone in Chicago Harbor during various periods from July 4, 2012 through July 28, 2012. This action is necessary and intended to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after fireworks events. Enforcement of this safety zone will establish restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after various fireworks events. During the enforcement period, no person or vessel may enter the safety zones without permission of the Captain of the Port, Sector Lake Michigan.

DATES:

The regulations in 33 CFR 165.931 will be enforced at various times between 9:00 p.m. on July 4, 2012 through 10:30 p.m. on July 28, 2012.

(1)Navy Pier Fireworks;on July 4, 2012 from 9:00 p.m. through 11:00 p.m.; on July 7, 2012 from 10:00 p.m. through 10:30 p.m.; on July 11, 2012 from 9:15 p.m. through 9:45 p.m.; on July 14, 2012 from 10:00 p.m. through 10:30 p.m.; on July 18, 2012 from 9:15 p.m. through 9:45 p.m.; on July 21, 2012 from 10:00 p.m. through 10:30 p.m.; on July 25, 2012 from 9:15 p.m. through 9:45 p.m.; and on July 28, 2012 from 10 through 10:30.

All vessels must obtain permission from the Captain of the Port, Sector Lake Michigan, or his or her on-scene representative to enter, move within or exit the safety zone. Vessels and persons granted permission to enter the safety zone shall obey all lawful orders or directions of the Captain of the Port, Sector Lake Michigan, or his or her on-scene representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.

This notice is issued under authority of 33 CFR 165.931 and 5 U.S.C. 552(a). In addition to this notice in theFederal Register, the Coast Guard will provide the maritime community with advance notification of these enforcement periods via broadcast Notice to Mariners or Local Notice to Mariners. The Captain of the Port, Sector Lake Michigan, will issue a Broadcast Notice to Mariners notifying the public when enforcement of the safety zone established by this section is suspended. If the Captain of the Port, Sector Lake Michigan, determines that the safety zone need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the safety zone. The Captain of the Port, Sector Lake Michigan, or his or her on-scene representative may be contacted via VHF Channel 16.

The EPA is making two separate and independent determinations. First, EPA is determining that the Springfield (Western Massachusetts) serious one-hour ozone nonattainment area did not meet the applicable deadline of December 31, 2003, for attaining the one-hour National Ambient Air Quality Standard (NAAQS) for ozone. This final determination is based upon complete, quality-assured, certified ambient air monitoring data that show the area had an expected ozone exceedance rate above the level of the now revoked one-hour ozone NAAQS for the 2001-2003 monitoring period. Second, EPA is determining that the Springfield (Western Massachusetts) serious one-hour ozone nonattainment area currently attains the now revoked one-hour NAAQS for ozone, based upon complete, quality-assured, certified ambient air monitoring data for 2009- 2011. The area first attained the one-hour NAAQS during the 2007-2009 monitoring period, and continued in attainment during the 2008-2010, and 2009-2011 monitoring periods.

DATES:

Effective Date:This rule is effective on May 30, 2012.

ADDRESSES:

EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2012-0008. All documents in the docket are listed on thewww.regulations.govweb site. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically throughwww.regulations.govor in hard copy at the Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square—Suite 100, Boston, MA. EPA requests that if at all possible, you contact the contact listed in theFOR FURTHER INFORMATION CONTACTsection to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding legal holidays.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

Organization of this document.The following outline is provided to aid in locating information in this preamble.

I. What actions is EPA taking?II. What is the effect of these actions?III. Final ActionsIV. Statutory and Executive Order ReviewsI. What Actions is EPA Taking?

EPA is making two separate and independent final determinations for the Springfield (Western Massachusetts) one-hour ozone serious nonattainment area (hereafter, “the Western Massachusetts area”).

A. Determination of Failure To Attain by Applicable Attainment Date

EPA is determining that the Western Massachusetts area did not attain the one-hour ozone National Ambient Air Quality Standard (NAAQS) by the applicable attainment date, December 31, 2003. This determination is based upon complete, quality-assured and certified air quality monitoring data for the 2001 through 2003 ozone seasons.

B. Determination of Current Attainment

In addition, EPA is determining that the Western Massachusetts area is currently attaining the one-hour ozone NAAQS based upon complete, quality-assured and certified ambient air monitoring data for 2009-2011 showing the area has attained the one-hour ozone NAAQS, and that it has done so continuously since the 2007-2009 monitoring period.

Additional information related to these determinations and the rationale for them are set forth in the Notice of Proposed Rulemaking (NPR) published on January 24, 2012 (77 FR 3417) and will not be restated here. EPA received no comments on the NPR.

II. What is the Effect of These Actions?

After revocation of the one-hour ozone standard, EPA must continue to provide a mechanism to give effect to one-hour ozone anti-backsliding requirements. SeeSCAQMDv.EPA,472 F.3d 882, at 903 (DC Cir. 2006). In keeping with this responsibility, EPA has determined that the Western Massachusetts area failed to attain the one-hour ozone standard by its applicable attainment date. Consistent with 40 CFR 51.905(e)(2), and the South Coast decision, upon revocation of the one-hour ozone NAAQS for an area, EPA is no longer obligated to determine whether an area has attained the one-hour NAAQS, except insofar as it relates to effectuating the anti-backsliding requirements that are specifically retained. EPA's determination here is linked solely to required one-hour anti-backsliding, contingency measures. A final determination of failure to attain will not result in reclassification of the area under the revoked one-hour standard, nor is EPA identifying or determining any new one-hour reclassification for the area. EPA is no longer required to reclassify an area to a higher classification for the one-hour ozone NAAQS based upon a determination that the area failed to attain that NAAQS by its attainment date. See 40 CFR 51.905(e)(2)(i)(B). Moreover, EPA has previously approved the one-hour ozone attainment demonstration and Reasonable Further Progress (ROP) plans for this area, and in doing so noted that although there were no state implementation plan contingency measure reductions applicable to the Western Massachusetts area for failure to attain, there were federal measures the state had not accounted for in its attainment demonstration that provided more reductions than necessary to serve the purpose of contingency measures for this area. See 66 FR 666, January 3, 2001. In addition, EPA has also determined that the Western Massachusetts area attained the one-hour ozone standard in 2009, and continues to attain this standard. In this context, EPA has also determined that there are not any additional obligations, including those relating to one-hour ozone contingency measures, for the Western Massachusetts area under the one-hour ozone standard.

III. Final Actions

EPA is determining that the Western Massachusetts one-hour ozone nonattainment area did not meet its applicable one-hour ozone attainment date of December 31, 2003, based on 2001-2003 complete, quality-assured ozone monitoring data. Separate from and independent of this determination, EPA is also determining that the Western Massachusetts one-hour ozone nonattainment area is currently attaining the one-hour ozone standard, based on the most recent three years (2009-2011) of complete, quality-assured ozone monitoring data at all monitoring sites in the area. EPA's review of the data shows that the area began attaining the one-hour ozone standard in the 2007-2009 period, and has continued to attain this standard through the 2008-2010 and 2009-2011 monitoring periods.

IV. Statutory and Executive Order Reviews

These actions make determinations of attainment based on air quality, result in the suspension of certain Federal requirements, and/or would not impose additional requirements beyond those imposed by state law. For that reason, these actions:

• Are not “significant regulatory actions” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Are certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Do not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Are not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, these actions do not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801et seq.,as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing these actions and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 29, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

(e) Determination of Attainment for the One-Hour Ozone Standard. Effective May 30, 2012, EPA is determining that the Springfield (Western Massachusetts) one-hour ozone nonattainment area did not meet its applicable one-hour ozone attainment date of December 31, 2003, based on 2001-2003 complete, quality-assured ozone monitoring data. Separate from and independent of this determination, EPA is determining that the Springfield (Western Massachusetts) one-hour ozone nonattainment area met the one-hour ozone standard, based on 2007-2009 complete, quality-assured ozone monitoring data at all monitoring sites in the area. EPA's review of the ozone data shows that the area began attaining the one-hour ozone standard during the 2007-2009 monitoring period, and has continued attaining the one-hour standard through the 2008-2010 and 2009-2011 monitoring periods.

EPA is taking final action to determine, pursuant to the Clean Air Act (CAA), that the bi-state St. Louis (MO-IL) ozone nonattainment area (“St. Louis area”) attained the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS) by the applicable attainment date of June 15, 2010. This determination is based upon complete, quality-assured, and certified ambient air quality data from the 2007-2009 monitoring period which show that the St. Louis area has monitored attainment of the 1997 8-hour ozone NAAQS as of the applicable date.

DATES:

Effective Date:This final rule will be effective May 30, 2012.

ADDRESSES:

EPA has established a docket for this action under Docket ID No. EPA-R07-OAR-2012-0053. All documents in the docket are listed on thewww.regulations.govWeb site. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically throughwww.regulations.govor in hard copy at the Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. EPA requests that if at all possible, you contact the person listed in theFOR FURTHER INFORMATION CONTACTsection to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:00 to 4:30 excluding Federal holidays.

Throughout this document, “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following questions:

Table of ContentsI. What final action is EPA taking in this final rule?II. What is the background for this final action?III. What was the air quality in the St. Louis area for the 1997 8-hour ozone NAAQS for the 2007-2009 monitoring period?IV. EPA's Final ActionV. Statutory and Executive Order ReviewsI. What final action is EPA taking in this final rule?

Pursuant to section 181(b)(2) of the CAA, EPA is taking final action to determine that the St. Louis area attained the 1997 8-hour ozone NAAQS by its applicable attainment date of June 15, 2010. The St. Louis area is composed of Jefferson County, Franklin County, St. Louis County, St. Louis City, and St. Charles County in Missouri, and Madison, Monroe, Jersey, and St. Clair Counties in Illinois. This determination is based upon complete, quality-assured and certified ambient air monitoring data from 2007-2009 which show that the St. Louis area monitored attainment of the 1997 8-hour ozone NAAQS as of its applicable attainment date.

On February 2, 2012, EPA published in theFederal Registera proposed rulemaking to determine that the St. Louis area attained the 1997 8-hour ozone NAAQS by its applicable attainment date of June 15, 2010 (see 77 FR 5210). EPA did not receive any public comments on this proposal.

II. What is the background for this action?

On July 18, 1997 (62 FR 38856), EPA promulgated an 8-hour ozone standard of 0.08 parts per million (ppm). On April 30, 2004 (69 FR 23858), EPA published a final rule designating and classifying areas under the 8-hour ozone NAAQS. These designations and classifications became effective June 15, 2004. EPA designated as nonattainment any area that was violating the 8-hour ozone NAAQS based on the three most recent years of air quality data, 2001-2003. Under EPA's implementation rule for the 1997 8-hour ozone standard (69 FR 23951, April 30, 2004), an area was classified under subpart 2 of the CAA based on its 8-hour ozone design value (i.e. the three-year average annual fourth-highest daily maximum 8-hour average ozone concentration), if it had a 1-hour design value at the time of designation at or above 0.121 ppm.See40 CFR 51.902(a). All other nonattainment areas were covered under subpart 1, based upon their 8-hour design values (69 FR 23958). The St. Louis area was classified as a subpart 2, 8-hour ozone moderate nonattainment area by EPA on April 30, 2004 (69 FR 23858, 23898 and 23915), based on the three most recent years of monitoring data (2001-2003), consistent with 40 CFR 51.903(a).

As a moderate nonattainment area for the 1997 8-hour ozone NAAQS, the St. Louis (MO-IL) area had an applicable attainment date of June 15, 2010, as required by 40 CFR 51.903(a) Table 1. Pursuant to section 181(b)(2) of the CAA, EPA is required to make a determination as to whether the St. Louis area attained the standard as of its applicable attainment date. This final action is based on the area's design value as of the attainment date, which in turn is based on the three most recent years of air quality data (2007-2009) prior to the attainment date.

III. What was the air quality in the St. Louis area for the 1997 8-hour ozone NAAQS for the 2007-2009 monitoring period?

Today's rulemaking assesses whether the St. Louis area attained the 1997 8-hour ozone NAAQS by its applicable attainment date of June 15, 2010. Under EPA regulations at 40 CFR 50.15, the 1997 8-hour primary and secondary ozone ambient air quality standards are met at an ambient air quality monitoring site when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration is less than or equal to 0.08 ppm, as determined in accordance with 40 CFR part 50, Appendix I. Based on the rounding convention set forth in section 2.3 of Appendix I, the smallest value that is greater than 0.08 ppm is 0.085 ppm.

EPA has reviewed the ambient air monitoring data for the St. Louis area for the 1997 8-hour ozone NAAQS, consistent with requirements contained at 40 CFR Part 50. EPA's review focused primarily on data recorded in the EPA Air Quality System (AQS) database for the St. Louis area for 2007-2009.

More detailed discussion of EPA's evaluation of the available monitoring data for the St. Louis area during the 2007-2009 monitoring period can be found in the proposal for this rulemaking (see77 FR at 5211). Based on its evaluation of complete quality assured and certified data from the relevant monitoring sites for the 2007-2009 monitoring period, EPA has determined that the St. Louis area attained the 1997 8-hour ozone NAAQS by the June 15, 2010 attainment date. EPA did not receive any comments on the proposed determination during the public comment period on the proposal.

Table 1 shows the 2007-2009 and 2008-2010 ozone design values for the St. Louis area monitors with complete, quality-assured and certified data for that period. All data values are expressed in ppm. As shown in Table 1, all of these monitors recorded ozonedesign values less than 0.085 ppm for 2007-2009 and 2008-2010, with the highest value at any monitor in the area, 0.078 ppm, recorded at the West Alton monitor.

Table 1—Annual Fourth-Highest Daily Maximum 8-Hour Ozone Concentrations and 3-Year Averages in ppm for the St. Louis Area Monitors With Complete Data[(2007-2009) and (2008-2010)]StateCountyMonitor2007

4th High

(ppm)

2008

4th High

(ppm)

2009

4th High

(ppm)

2010

4th High

(ppm)

2007-2009 Design

Value

(ppm)

2008-2010 Design

Value

(ppm)*

IllinoisJerseyJerseyville

17-083-1001

0.0750.0690.0680.0720.0700.069MadisonAlton

17-119-0008

0.0810.0680.0670.0800.0720.071Maryville

17-119-1009

0.0870.0700.0740.0740.0770.072Wood River

17-119-3007

0.0860.0670.0660.0700.0730.067St. ClairEast St. Louis

17-163-0010

0.0770.0640.0690.0720.0700.068MissouriSt. CharlesWest Alton

29-183-1002

0.0890.0760.0710.0840.0780.077Orchard Farm

29-183-1004

0.0830.0720.0730.0770.0760.074St. LouisMaryland Heights

29-189-0014

0.0940.0690.0700.0760.0770.071Pacific

29-189-0005

0.0850.0640.0640.0690.0710.065St. Louis CityBlair Street

29-510-0085

0.0870.0730.0650.0710.0750.069* Although the determination here is whether the area attained the 1997 8-hour ozone NAAQS based on 2007-2009 data, the 2010 data shows that all monitors in the St. Louis area continued to attain the NAAQS in 2008-2010.

Based on its evaluation of complete quality assured and certified data from the relevant monitoring sites for the 2007-2009 monitoring period, EPA has determined that the St. Louis area attained the 1997 8-hour ozone NAAQS by the June 15, 2010 attainment date.

IV. EPA's Final Action

In today's rulemaking, pursuant to CAA section 181(b)(2), EPA is taking final action to determine that the St. Louis area has attained the 1997 8-hour ozone NAAQS by its applicable attainment date of June 15, 2010.

V. Statutory and Executive Order Reviews

This final action merely makes a determination of the St. Louis area's attainment of the 1997 8-hour ozone NAAQS based upon complete, quality-assured, and certified ambient air quality data, pursuant to statutory mandate, and does not impose additional requirements beyond those imposed by state law. This final action makes a non-discretionary determination of the St. Louis area's attainment of the 1997 8-hour ozone NAAQS based solely upon complete, quality-assured, and certified ambient air quality data, as mandated by CAA section 181(b)(2)(A). For that reason, this final action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this final action does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the determination only affects the St. Louis area—which does not include Indian country—and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801et seq.,as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the UnitedStates prior to publication of the rule in theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 29, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (Seesection 307(b)(2).)

(kk)Determination of attainment.EPA has determined, as of June 9, 2011, that the St. Louis (MO-IL) metropolitan 1997 8-hour ozone nonattainment area has attained the 1997 8-hour ozone NAAQS. This determination, in accordance with 40 CFR 51.918, suspends the requirements for this area to submit an attainment demonstration, associated reasonably available control measures, reasonable further progress, contingency measures, and other plan elements related to attainment of the standards for as long as the area continues to meet the 1997 Ozone NAAQS. In addition, based upon EPA's review of the air quality data for the 3-year period 2007 to 2009, the St. Louis (MO-IL) ozone nonattainment area has attained the 1997 8-hour ozone NAAQS by the applicable attainment date of June 15, 2010.

(a) Determination of attainment. EPA has determined, as of June 9, 2011, that the St. Louis (MO-IL) metropolitan 1997 8-hour ozone nonattainment area has attained the 1997 8-hour ozone NAAQS. This determination, in accordance with 40 CFR 51.918, suspends the requirements for this area to submit an attainment demonstration, associated reasonably available control measures, reasonable further progress, contingency measures, and other plan elements related to attainment of the standards for as long as the area continues to meet the 1997 Ozone NAAQS. In addition, based upon EPA's review of the air quality data for the 3-year period 2007 to 2009, the St. Louis (MO-IL) ozone nonattainment area has attained the 1997 8-hour ozone NAAQS by the applicable attainment date of June 15, 2010.

The Resource Conservation and Recovery Act of 1976 (RCRA), as amended, authorizes the United States Environmental Protection Agency (EPA) to grant approval to any State to operate its underground storage tank program in the State in lieu of the federal program. The regulation codifies EPA's decision to approve State programs and incorporates by reference those provisions of the State statutes and regulations that will be subject to EPA's inspection and enforcement authorities under sections 9005 and 9006 of RCRA subtitle I and other applicable statutory and regulatory provisions. This rule codifies the prior approval of Oregon's underground storage tank program and incorporates by reference appropriate provisions of state statutes and regulations.

DATES:

This regulation is effective June 29, 2012, unless EPA publishes a priorFederal Registerdocument withdrawing this direct final rule. All comments on the codification of Oregon's underground storage tank program must be received by the close of business May 30, 2012. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register, as of June 29, 2012, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

ADDRESSES:

Comments may be submitted, identified by Docket ID No. EPA-R10-UST-2011-0097, by one of the following methods:

• Comments received by EPA may be inspected in the public docket online and in the EPA Region 10 Library, 1200 Sixth Avenue, Seattle, WA 98101, from 9 a.m. to 12 p.m. and 1 p.m. to 4 p.m., Monday through Friday, excluding Federal holidays.

Instructions:Direct your comments to Docket ID No. EPA-R10-UST-2011-0097. EPA's policy is that all comments received will be included in the public docket without change and may be made available online athttp://www.regulations.gov,including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected throughhttp://www.regulations.govor email. Thehttp://www.regulations.govWeb site is an “anonymous access” system, which means EPA will not know your identify or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going throughhttp://www.regulations.govyour email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with anydisk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters or any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage athttp://www.epa.gov/epahome/dockets.htm.

Docket:All documents in the docket are listed in thehttp://www.regulations.govindex. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically inhttp://www.regulations.govor in hard copy.

Section 9004 of the Resource Conservation and Recovery Act of 1976 (RCRA), as amended, 42 U.S.C. 6991c, authorizes the United States Environmental Protection Agency (EPA) to approve a State to operate its underground storage tank program in the State in lieu of the federal underground storage tank program. EPA published aFederal Registerdocument announcing its decision to grant approval to Oregon on September 16, 2011, and approval was effective on September 16, 2011 (76 FR 57659).

EPA codifies its approval of State programs in 40 CFR part 282 and incorporates by reference therein those provisions of the State statutes and regulations that are subject to EPA's inspection and enforcement authorities under sections 9005 and 9006 of subtitle I of RCRA, 42 U.S.C. 6991d and 6991e, and other applicable statutory and regulatory provisions. Today's rulemaking codifies EPA's approval of Oregon's underground storage tank program. This codification reflects the State program in effect at the time EPA grants Oregon approval under section 9004, 42 U.S.C. 6991c, for its underground storage tank program. Notice and opportunity for comment were provided earlier on the Agency's decision to approve the Oregon program, and EPA is not now reopening that decision nor requesting comment on it.

This effort provides clear notice to the public of the scope of the approved program in each state. By codifying the approved Oregon program and by amending the Code of Federal Regulations (CFR) whenever a new or different set of requirements is approved in Oregon, the status of federally-approved requirements of the Oregon program will be readily discernible. Only those provisions of the Oregon underground storage tank program EPA has approved will be incorporated by reference for enforcement purposes.

To codify EPA's approval of Oregon's underground storage tank program, EPA has added § 282.87 to Title 40 of the CFR. Section 282.87(d)(1)(i) incorporates by reference for enforcement purposes the State's statutes and regulations. Section 282.87 also references the Attorney General's Statement, Demonstration of Adequate Enforcement Procedures, the Program Description, and the Memorandum of Agreement, which are approved as part of the underground storage tank program under subtitle I of RCRA.

EPA retains the authority under sections 9003(h), 9005 and 9006 of subtitle I of RCRA, 42 U.S.C. 6991b(h), 6991d and 6991e, and other applicable statutory and regulatory provisions to undertake corrective actions, inspections and enforcement in approved States. With respect to such actions, EPA will rely on federal sanctions, federal inspection authorities, and federal procedures rather than the State authorized analogues to these provisions. Therefore, the approved Oregon enforcement authorities will not be incorporated by reference. Section 282.87 lists those approved Oregon authorities that would fall into this category.

The public also needs to be aware that some provisions of the State's underground storage tank program are not part of the federally-approved State program, because such provisions are “broader in scope” than subtitle I of RCRA. See 40 CFR 281.12(a)(3)(ii). As a result, State provisions which are “broader in scope” than the federal program are not incorporated by reference for purposes of enforcement in Part 282. Section 282.87 of the codification simply lists for reference and clarity the Oregon statutory and regulatory provisions which are “broader in scope” than the federal program and which are not, therefore, part of the approved program being codified today. “Broader in scope” provisions cannot be enforced by EPA; the State, however, will continue to implement and enforce such provisions.

B. Statutory and Executive Order Review

This final rule only applies to Oregon's UST Program requirements pursuant to RCRA Section 9004 and imposes no requirements other than those imposed by State law. It complies with applicable EOs and statutory provisions as follows:

1. Executive Order 12866

The Office of Management and Budget (OMB) has exempted this rule from its review under Executive Order 12866.

2. Paperwork Reduction Act

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501et seq.,because this rule does not establish or modify any information or recordkeeping requirements for the regulated community and only seeks to authorize the pre-existing requirements under State law and imposes no additional requirements beyond those imposed by State law.

3. Regulatory Flexibility Act

After considering the economic impacts of today's rule on small entities under the Regulatory Flexibility Act, I certify that this rule will not have a significant economic impact on a substantial number of small entities because the rule will only have the effect of authorizing pre-existing requirements under State law and imposes no additional requirements beyond those imposed by State law.

4. Unfunded Mandates Reform Act

Because today's rulemaking codifies pre-existing requirements under Oregon state law and does not impose any additional enforceable duty beyond that required by Oregon state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act.

5. Executive Order 13132: Federalism

Executive Order 13132 does not apply to this rule because this final rule does not have Federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government.

6. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

Executive Order 13175 does not apply because this rule does not have tribal implications (i.e., substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes). EPA retains its authority in Indian Country.

7. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it will codify a state program.

8. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use

This rule is not subject to Executive Order 13211 because it is not a “significant regulatory action” as defined under Executive Order 12866.

9. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), (15 U.S.C. 272), directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This rulemaking does not involve technical standards. Therefore, the NTTAA does not apply.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This rule does not affect the level of protection provided to human health or the environment because this rule codifies pre-existing State rules which are no less stringent than existing Federal requirements.

11. Submission to Congress and the General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business Regulatory Enforcement Fairness Act of 1996, EPA submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the General Accounting Office prior to publication of the rule in today'sFederal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

(a) The State of Oregon is approved to administer and enforce an underground storage tank program in lieu of the federal program under subtitle I of the Resource Conservation and Recovery Act of 1976 (RCRA), as amended, 42 U.S.C. 6991et seq.The State's program, as administered by the Oregon Department of Environmental Quality, was approved by EPA pursuant to 42 U.S.C. 6991c and Part 281 of this Chapter. EPA published the notice of final determination approving the Oregon underground storage tank program on September 16, 2011, and it became effective on that date.

(b) Oregon has primary responsibility for enforcing its underground storage tank program. However, EPA retains the authority to exercise its corrective action, inspection and enforcement authorities under sections 9003(h), 9005 and 9006 of subtitle I of RCRA, 42 U.S.C. 6991b(h), 6991d and 6991e, as well as its authority under other statutory and regulatory provisions.

(c) To retain program approval, Oregon must revise its approved program to adopt new changes to the federal subtitle I program which make it more stringent, in accordance with section 9004 of RCRA, 42 U.S.C. 6991c, and 40 CFR part 281, subpart E. If Oregon obtains approval for the revised requirements pursuant to section 9004 of RCRA, 42 U.S.C. 6991c, the newly approved statutory and regulatory provisions will be added to this subpart and notice of any change will be published in theFederal Register.

(d) Oregon has final approval for the following elements submitted to EPA in its program application as of September 16, 2011.

(1)State statutes and regulations.(i) The provisions cited in this paragraph are incorporated by reference as part of the underground storage tank program under subtitle I of RCRA, 42 U.S.C. 6991et seq.with the approval of the Director of theFederal Registerunder 5 U.S.C. 552(a) and 1 CFR Part 51. To enforce any edition other than that specified in this section, the Environmental Protection Agency must publish notice of change in theFederal Registerand the material must be available to the public. All approved material is available for inspection at the National Archives and Records Administration (NARA). For information on the availability of the material at NARA, call 202-741-6030 or go tohttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copies of Oregon's program application may be obtained from the Underground Storage Tank Program, Oregon Department of Environmental Quality, 811 SW Sixth Avenue, Portland, Oregon, 97204.

(2) Chapter 465, Hazardous Waste and Hazardous Materials I (Removal or Remedial Action: Sections 465.200-465.482 and 465.900), insofar as these provisions apply to matters involving an “underground storage tank” as that term is defined in ORS 466.706(21), as limited by the exclusions listed in ORS 466.710, except that the term does not include a tank used for storing heating oil for consumptive use on the premises where stored. The following Sections are part of the approved state program, although not incorporated by reference herein for enforcement purposes: Sections 465.205 through 465.250, 465.257 through 465.300, 465.310 through 465.335, 465.400 through 465.435, 465.445 through 465.455 and 465.900.

(3) Chapter 466, Hazardous Waste and Hazardous Materials II (Oil Storage Tanks: Sections 466.706-466.920 and Sections 466.990-466.995), insofar as these provisions apply to matters involving an “underground storage tank” as that term is defined in ORS 466.706(21), as limited by the exclusions listed in ORS 466.710, except that the term does not include a tank used for storing heating oil for consumptive use on the premises where stored. The following Sections are part of the approved state program, although not incorporated by reference herein for enforcement purposes: Sections 466.715 through 466.735, 466.746, 466.760, 466.775 through 466.780, 466.791 through 466.810, 466.820, 466.830 through 466.845, 466.901 through 466.920 and 466.994 through 466.995.

(4) Chapter 468 Environmental Quality Generally, insofar as these provisions apply to matters involving an “underground storage tank” as that term is defined in ORS 466.706(21), as limited by the exclusions listed in ORS 466.710, except that the term does not include a tank used for storing heating oil for consumptive use on the premises where stored. The following Sections are part of the approved state program, although not incorporated by reference herein for enforcement purposes: Sections 468.005 through 468.050, 468.090 through 468.140 and 468.963.

(7) Oregon Administrative Rules, Chapter 690, Division 240, insofar as these provisions apply to matters involving an “underground storage tank” as that term is defined in ORS 466.706(21), as limited by the exclusions listed in ORS 466.710, except that the term does not include a tank used for storing heating oil for consumptive use on the premises where stored. The following Sections are part of the approved state program, although not incorporated by reference herein for enforcement purposes: Sections 690-240-0015, 690-240-0020, 690-240-0055 through 690-240-0340 and 690-240-0560 through 690-240-0640.

(iii) The following specifically identified sections and rules applicable to the Oregon underground storage tank program that are broader in scope than the federal program, are not part of the approved program, and are not incorporated by reference herein for enforcement purposes.

(2) Statement of legal authority. The Attorney General Statement, a letter signed on June 21, 2010, though not incorporated by reference, is referenced as part of the approved underground storage tank program under subtitle I of RCRA, 42 U.S.C. 6991 et seq.

(3) Demonstration of procedures for adequate enforcement. The “Demonstration of Procedures for Adequate Enforcement” submitted as part of the application for approval on July 19, 2010, though not incorporated by reference, is referenced as part of the approved underground storage tank program under subtitle I of RCRA, 42 U.S.C. 6991et seq.

(4)Program Description.The program description and any other material submitted as part of the application on July 19, 2010, though not incorporated by reference, are referenced as part of the approved underground storage tank program under subtitle I of RCRA, 42 U.S.C. 6991et seq.

(5)Memorandum of Agreement.The Memorandum of Agreement between EPA Region 10 and the Oregon Department of Environmental Quality, signed by the EPA, Regional Administrator on July 11, 2011, though not incorporated by reference, is referenced as part of the approved underground storage tank program under subtitle I of RCRA, 42 U.S.C. 6991et seq.

3. Appendix A to Part 282 is amended by adding in alphabetical order “Oregon” and its listing.Appendix A to Part 282—State Requirements Incorporated by Reference in Part 282 of the Code of Federal RegulationsOregon

465.200Definitions for ORS 465.200 to 465.545 (except for Sections 465.200(5) through (11) and (17) defining terms contained in the dry cleaning requirements; (13) “facility” insofar as it applies to a facility that is not an underground storage tank; (16) “hazardous substance” insofar as it applies to hazardous wastes and any substance that is not otherwise defined as a hazardous substance pursuant to section 101(14) of the federal Comprehensive Environmental Response, Compensation and Liability Act or that is not oil; (28) “underground storage tank” insofar as it includes any tank or piping that is excluded under ORS 466.710 and also any tank used to store heating oil for consumptive use on the premises where stored.)

465.255Strict liability for remedial action costs for injury or destruction of naturalresource; limited exclusions (except insofar as this includes a person who is not an owner or operator of an underground storage tank and except insofar as the exclusions would exclude persons who would be liable under Section 9003(h)(6) of RCRA).

466.706Definitions for ORS 466.706 to 466.882 and 466.994 (except for the following definitions: Section 466.706(17) “regulated substance” insofar as it would include substances designated by the commission under subsection (c) that are not included under subsections (a) and (b) of this definition; (21) “underground storage tank” insofar as it includes any tank or piping that is excluded under ORS 466.710, and any tank used to store heating oil for consumptive use on the premises where stored.)

466.710Application of ORS 466.706 to 466.882 and 466.994466.740Noncomplying installation prohibited466.743Training on operation, maintenance and testing; rules466.765Duty of owner or permittee of underground storage tank466.770Corrective action required on contaminated site466.815Financial responsibility of owner or permittee; rules; legislative review466.825Strict liability of owner or permittee

(b) The regulatory provisions include:

(1) Oregon Administrative Rules, Chapter 340, Division 122 insofar as the following rules apply to a release from an underground storage tank, excluding tanks used to store heating oil for consumptive use on the premises where stored.

340-122-0010Purpose340-122-0030Scope and Applicability340-122-0040Standards340-122-0047Generic remedies340-122-0050Activities340-122-0070Removal340-122-0071Site Evaluation340-122-0072Preliminary Assessments340-122-0073Confirmation of Release340-122-0080Remedial Investigation340-122-0084Risk Assessment340-122-0085Feasibility Study340-122-0090Selection or Approval of the Remedial Action340-122-0100Public Notice and Participation340-122-0110Administrative Record340-122-0115Definitions insofar as the definition applies to an underground storage tank, excluding tanks used to store heating oil for consumptive use on the premises where stored340-122-0120Security Interest Exemption340-122-0205Purpose340-122-0210Definitions except insofar as the definition of “responsible person” includes a person who does not own or operate an underground storage tank340-122-0215Scope and Applicability340-122-0217Requirements and Remediation Options340-122-0218Sampling and Analysis340-122-0220Initial Response340-122-0225Initial Abatement Measures and Site Check340-122-0230Initial Site Characterization340-122-0235Free Product Removal340-122-0240Investigation for Magnitude and Extent of Contamination340-122-0243Low-Impact Sites340-122-0244Risk-Based Concentrations340-122-0250Corrective Action Plan340-122-0252Generic Remedies340-122-0260Public Participation340-122-0320Soil Matrix Cleanup Options340-122-0325Evaluation of Matrix Cleanup Level340-122-0330Evaluation Parameters340-122-0335Numeric Soil Cleanup Standards340-122-0340Sample Number and Location340-122-0345Sample Collection Methods340-122-0355Evaluation of Analytical Results340-122-0360Reporting RequirementsGrid for OAR 340-122-0330(5)(c) and Table for OAR 340-122-0335(2)

(2) Oregon Administrative Rules, Chapter 340, Division 142 insofar as the following rules apply to a release from an underground storage tank, excluding tanks used to store heating oil for consumptive use on the premises where stored.

340-142-0001Purpose and Scope340-142-0005Definitions as Used in This Division Unless Otherwise Specified340-142-0030Emergency Action340-142-0040Required Reporting340-142-0050Reportable Quantities340-142-0060Cleanup Standards340-142-0070Approval Required for Use of Chemicals340-142-0080Disposal of Recovered Spill Materials340-142-0090Cleanup Report340-142-0100Sampling/Testing Procedures340-142-0130Incident Management and Emergency Operations

(3) Oregon Administrative Rules, Chapter 340, Division 150.

340-150-0001Purpose340-150-0006Applicability and General Requirements340-150-0008Exemptions and Deferrals340-150-0010Definitions340-150-0020UST General Permit Registration Certificate Required except insofar as this provision applies to a person who does not own or operate an underground storage tank and except insofar as the payment of fees is required340-150-0021Termination of Temporary Permits340-150-0052Modification of Registration Certificates for Changes in Ownership and Permittee except insofar as the payment of fees is required340-150-0080Denial, Suspension or Revocation of General Permit Registration Certificates except insofar as this provision applies to a person who does not own or operate an underground storage tank340-150-0102Termination of Registration Certificates340-150-0110UST General Permit Registration, Annual Compliance and Other Fees except insofar as the payment of fees is required340-150-0135General Requirements for Owners and Permittees340-150-0140Requirements for Sellers of USTs340-150-0156Performance of UST Services by Owners or Permittees340-150-0160General Permit Requirements for Installing an UST System except insofar as this provision applies to a person who does not own or operate an underground storage tank340-150-0163General Permit Requirements for Operating an UST System except insofar as the payment of fees is required340-150-0166General Permit Requirements for Closure of an UST System by Change-in-Service except insofar as the payment of fees is required340-150-0167General Permit Requirements for Temporary Closure of an UST System except insofar as the payment of fees is required340-150-0168General Permit Requirements for Decommissioning an UST System by Permanent Closure except insofar as this provision applies to a person who does not own or operate an underground storage tank and except insofar as the payment of fees is required340-150-0180Site Assessment Requirements for Permanent Closure or Change-in-Service340-150-0200Training Requirements for UST System Operators andEmergency Response Information340-150-0210Training Requirements for UST Operators340-150-0300Installation of USTs and Piping340-150-0302Installation of Used USTs340-150-0310Spill and Overfill Prevention Equipment and Requirements340-150-0320Corrosion Protection Performance Standards for USTs and Piping340-150-0325Operation and Maintenance of Corrosion Protection340-150-0350UST System Repairs340-150-0352UST System Modifications and Additions340-150-0354UST System Replacements340-150-0360Requirements for Internally Lined USTs340-150-0400General Release Detection Requirements for Petroleum UST Systems340-150-0410Release Detection Requirements and Methods for Underground Piping340-150-0420Release Detection Requirements for Hazardous Substance UST Systems340-150-0430Inventory Control Method of Release Detection340-150-0435Statistical Inventory Reconciliation Method of Release Detection340-150-0440Manual Tank Gauging Release Detection Method340-150-0445Tank Tightness Testing for Release Detection and Investigation340-150-0450Automatic Tank Gauging Release Detection Method340-150-0455Vapor Monitoring Release Detection Method340-150-0460Groundwater Monitoring Release Detection Method340-150-0465Interstitial Monitoring Release Detection Method340-150-0470Other Methods of Release Detection340-150-0500Reporting Suspected Releases340-150-0510Suspected Release Investigation and Confirmation Steps340-150-0520Investigation Due to Off Site Impacts340-150-0540Applicability to Previously Closed UST Systems340-150-0550Definitions for OAR 340-150-0555 and 340-150-0560340-150-0555Compliance Dates for USTs and Piping340-150-0560Upgrading Requirements for Existing UST SystemsAPPENDIX AInstallation of USTs and PipingAPPENDIX BInstallation of USTs and PipingAPPENDIX CSpill and Overfill Prevention Equipment and RequirementsAPPENDIX D1USTs Corrosion Protection Performance Standards for USTs and PipingAPPENDIX D2Piping Corrosion Protection Performance Standards for USTs and PipingAPPENDIX E1USTs Corrosion Protection Performance Standards for USTs and PipingAPPENDIX E2Piping Corrosion Protection Performance Standards for USTs and PipingAPPENDIX FCorrosion Protection Performance Standards for USTs and PipingAPPENDIX GOperation and Maintenance of Corrosion ProtectionAPPENDIX HUST System Repairs & UST System Modifications and AdditionsAPPENDIX IGeneral Release Detection Requirements for All UST SystemsAPPENDIX JGeneral Guidance Documents for UST Owners and PermitteesAPPENDIX KSite Assessment Requirements for Permanent Closure or Change-in-ServiceAPPENDIX LTraining Elements

(4) Oregon Administrative Rules, Chapter 340, Division 151

340-151-0001Purpose340-151-0010Scope and Applicability340-151-0015Adoption and Applicability of United States Environmental Protection Agency Regulations340-151-0020Definitions340-151-0025Oregon-Specific Financial Responsibility Requirements

(5) Oregon Administrative Rules, Chapter 690, Division 240, insofar as it pertains to underground storage tanks, excluding tanks used to store heating oil for consumptive use on the premises where stored.

FMCSA harmonizes its regulations with a recent Surface Transportation Board (STB) order that requires certain information about household goods motor carrier liability to appear on the estimates and bills of lading that carriers must provide to individual shippers.

DATES:

This final rule is effective May 15, 2012.

ADDRESSES:

Documents mentioned in this rule are available for inspection or copying in the docket, Docket No. FMCSA-2012-0101 available atwww.regulations.gov,and at the Docket Management Facility, U.S. Department of Transportation, Ground floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays.

The Secretary of Transportation's (Secretary) general jurisdiction to establish regulations over transportation of property by motor carrier is found at 49 U.S.C. 13501. Household goods motor carriers are a subset of all property motor carriers and are required by 49 U.S.C. 13902 to register with FMCSA as household goods motor carriers.

The ICC Termination Act of 1995 (Pub. L. 104-88, 109 Stat. 803, Dec. 29, 1995) abolished the Interstate Commerce Commission (ICC), which previously had jurisdiction over the commercial activities of household goods motor carriers. Its functions relating to household goods carriers were split between the STB and the Secretary. The STB was given jurisdiction over most tariff issues, while the Secretary was given jurisdiction over consumer protection matters.

The Secretary has delegated these authorities to the FMCSA Administrator (49 CFR 1.73(a)). This rulemaking applies only to household goods motor carriers that provide for-hire transportation in interstate or foreign commerce.

FMCSA implements this final rule without notice and comment pursuant to 5 U.S.C. 553(b)(B). While the Administrative Procedure Act (APA) normally requires issuance of a notice of proposed rulemaking and an opportunity for public comment, the APA provides an exception when an agency “for good cause finds * * * that notice and public procedure * * * are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B). This final rule updates 49 CFR part 375 to reflect recent changes the STB made to its requirements after engaging in notice and commentrulemaking.See Released Rates of Motor Common Carriers of Household Goods,Surface Transportation Board, Docket No. RR 999 (Amendment No. 5), Order, Jan. 10, 2012 (Released Rates Order). These changes fall within the STB's jurisdiction and FMCSA does not have authority to exercise discretion in implementing them. Therefore, FMCSA finds that the opportunity for notice and public comment is unnecessary and contrary to the public interest under the APA.

II. Background

STB is charged with the oversight of household goods motor carriers' tariffs. Tariffs include the rates and terms under which household goods carriers may provide transportation services. In accordance with 49 U.S.C. 14706(f)(3), the Board authorizes household goods carriers to set “released rates,” which are lower rates for transportation services when the shipper agrees to release the carrier from full liability for potential loss and damage to the shipper's cargo. There are currently two generally applicable liability options for interstate household goods moves. The first reimburses the shipper for the replacement value of his or her goods, referred to as the full value option. The second reimburses the shipper at a lower rate, currently 60 cents per pound, and is referred to as the released rate option. The Board's rules provide that any rate a carrier charges for transportation services, whether under the full liability option or the released rate option, must be published in the carrier's tariff.

In a decision served January 21, 2011, the STB implemented a congressional directive to enhance consumer protection in cases of loss or damage that occur during interstate moves.SeeSafe, Accountable, Flexible, Efficient Transportation Act: A Legacy for Users (SAFETEA-LU), § 4215, Public Law 109-59, 119 Stat. 1144, 1760 (2005). That decision required household goods motor carriers to provide certain information concerning the two available cargo liability options to shippers on written estimates for household goods transportation. On January 12, 2012, STB served another decision clarifying and modifying certain aspects of the January 2011 decision. STB modified the order to require household goods movers to place the following liability election notice on the estimates they provide to prospective shippers:

WARNING: If a moving company loses or damages your goods, there are 2 different standards for the company's liability based on the types of rates you pay. BY FEDERAL LAW, THIS FORM MUST CONTAIN A FILLED-IN ESTIMATE OF THE COST OF A MOVE FOR WHICH THE MOVING COMPANY IS LIABLE FOR THE FULL (REPLACEMENT) VALUE OF YOUR GOODS in the event of loss of, or damage to, the goods. This form may also contain an estimate of the cost of a move in which the moving company is liable for FAR LESS than the replacement value of your goods, typically at a lower cost to you. You will select the liability level later, on the bill of lading (contract) for your move. Before selecting a liability level, please read “Your Rights and Responsibilities When You Move,” provided by the moving company, and seek further information at the government Web sitewww.protectyourmove.gov.

Released Rates Order,Appendix 1.

That decision also directed household goods motor carriers to provide the STB's required valuation statement on the shipper's bill of lading. The valuation statement includes specific language that requires the consumer either to choose the replacement value option and declare a total value for the shipment, or choose the released rate option. This statement is much lengthier than the notice carriers must include in the estimate and contains specific information about the cost to the shipper.Released Rates Order,Appendix 2. These requirements go into effect May 15, 2012.See Released Rates of Motor Common Carriers of Household Goods,Surface Transportation Board, Docket No. RR 999 (Amendment No. 5), Order, Mar. 8, 2012 (extending compliance date) (77 FR 15187).

FMCSA is charged with overseeing consumer protection matters related to the transportation of household goods. In this capacity, FMCSA administers regulations requiring household goods motor carriers to provide estimates and certain shipping documents to individual shippers and establishes the terms and conditions under which those documents must be provided.

STB's January 2012 order affects FMCSA's regulations because it mandates that specific language regarding carriers' rates and liability be placed on the estimates and bills of lading that FMCSA requires carriers to provide to prospective shippers. As a result, FMCSA amends its regulations governing those documents to reflect the STB's new requirements.

III. Discussion of the Rule

FMCSA amends 49 CFR 375.401 and 375.505 to eliminate inconsistencies resulting from the STB's recent publication of its Released Rates Order. These changes incorporate the STB's new requirements into FMCSA's regulations governing estimates and bills of lading.

FMCSA amends § 375.401 by adding a new paragraph (g) which states that household goods motor carriers must include STB's liability election notice on all written estimates. This notice is a brief statement advising prospective shippers that they will have to select one of two options that govern the extent of the carrier's liability for damage to their cargo. New paragraph (g) directs household goods motor carriers to use the language set forth in the STB Released Rates Order. FMCSA redesignates old paragraphs (g) and (h) as new paragraphs (h) and (i) respectively.

FMCSA also amends § 375.505 to make it clear that the STB's valuation statement, a lengthier statement which requires shippers to select one of the two levels of liability, must appear on the shipper's bill of lading. Previously, § 375.505(e) permitted carriers to provide the valuation statement on either the bill of lading or the order for service. FMCSA removes paragraph (e) and revises subparagraph (b)(12) to make conforming changes to remove any ambiguity about where the valuation statement must appear.

IV. Regulatory AnalysesA. Regulatory Planning and Review

FMCSA has determined that this action does not meet the criteria for a “significant regulatory action,” either as specified in Executive Order 12866 as supplemented by Executive Order 13563 (76 FR 3821, January 18, 2011), or within the meaning of the DOT regulatory policies and procedures (44 FR 1103, February 26, 1979). The estimated economic costs of the rule do not exceed the $100 million annual threshold and the Agency does not expect the rule to have substantial congressional or public interest. Therefore, this rule has not been formally reviewed by the Office of Management and Budget.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857), FMCSA is not required to prepare a final regulatory flexibility analysis under 5 U.S.C. 604(a) for this final rule because the Agency has not issued a notice of proposed rulemaking prior to this action.

C. Federalism (Executive Order 13132)

A rule has federalism implications if the rule has a substantial direct effect on State or local governments and would either preempt State law or impose asubstantial direct cost of compliance on the States. FMCSA analyzed this rule under E.O. 13132 and has determined that it does not have federalism implications.

D. Unfunded Mandates Reform Act of 1995

This final rule does not impose an unfunded Federal mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532et seq.), that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $143.1 million (which is the value of $100 million in 2010 after adjusting for inflation) or more in any 1 year.

E. Executive Order 12988 (Civil Justice Reform)

This final rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

F. Executive Order 13045 (Protection of Children)

FMCSA analyzed this action under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. The Agency determined that this rule will not create an environmental risk to health or safety that may disproportionately affect children.

G. Executive Order 12630 (Taking of Private Property)

FMCSA reviewed this final rule in accordance with Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it will not affect a taking of private property or otherwise have taking implications.

H. Privacy Impact Assessment

Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a privacy impact assessment (PIA) of a regulation that will affect the privacy of individuals. This rule does not require the collection of any personally identifiable information.

The Privacy Act (5 U.S.C. 552a) applies only to Federal agencies and any non-Federal agency which receives records contained in a system of records from a Federal agency for use in a matching program. FMCSA has determined this rule will not result in a new or revised Privacy Act System of Records for FMCSA.

I. Executive Order 12372 (Intergovernmental Review)

The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.

J. Paperwork Reduction Act

Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.), Federal agencies must obtain approval from the Office of Management and Budget for each collection of information they conduct, sponsor, or require through regulations. The changes in this rule are mandated by the STB, exercising its authority over household goods motor carriers' tariffs. Any change to the paperwork burden associated with these requirements is required to be accounted for by the STB in connection with itsReleased Rates Order.As this rule merely incorporates the STB's requirements, FMCSA does not conduct, sponsor or require any additional information collection through this rule.

K. National Environmental Policy Act and Clean Air Act

FMCSA analyzed this rule in accordance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321et seq.). The Agency has determined under its environmental procedures Order 5610.1, published in theFederal RegisterMarch 1, 2004 (69 FR 9680), that this action is categorically excluded from further environmental documentation under Appendix 2, Paragraph 6(b) of the Order (69 FR 9702). This categorical exclusion (CE) relates to regulations that are editorial in nature making technical corrections and minor amendments, which applies to this rule as FMCSA is simply aligning its regulations with the STB's regulations. Environmental impacts, if any, would have been analyzed during the rulemaking by STB. In addition, the Agency believes this rule presents no extraordinary circumstances that will have any effect on the quality of the environment. Thus, the action does not require an environmental assessment or an environmental impact statement.

FMCSA also analyzed this rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 7401et seq.), and implementing regulations promulgated by the Environmental Protection Agency. Approval of this action is exempt from the CAA's general conformity requirement since it does not affect direct or indirect emissions of criteria pollutants.

L. Executive Order 13211 (Energy Effects)

FMCSA has analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use. The Agency has determined that it is not a “significant energy action” under that Executive Order because it is not economically significant and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

2. In § 375.401, redesignate paragraphs (g) and (h) as paragraphs (h) and (i), and add new paragraph (g) to read as follows:§ 375.401Must I estimate charges?

(g) You must include as a part of your estimate the liability election notice provided in the Surface Transportation Board's released rates order. Contact the STB for a copy of the Released Rates of Motor Carrier Shipments of Household Goods.

3. In § 375.505, revise paragraph (b)(12) and remove paragraph (e) to read as follows:§ 375.505Must I write up a bill of lading?

(b)(12) The valuation statement provided in the Surface Transportation Board's released rates order requires individual shippers either to choose Full Value Protection for your liability or waive the Full Value Protection in favor of the STB's released rates. The released rates may be increasedannually by the motor carrier based on the U.S. Department of Commerce's Cost of Living Adjustment. Contact the STB for a copy of the Released Rates of Motor Carrier Shipments of Household Goods. If the individual shipper waives your Full Value Protection in writing on the STB's valuation statement, you must include the charges, if any, for optional valuation coverage (other than Full Value Protection).

The U.S. Nuclear Regulatory Commission (NRC or the Commission) is publishing for public comment a notice of receipt for a petition for rulemaking (PRM), dated February 15, 2012, which was filed with the NRC by Mr. Michael Mariotte on behalf of the Nuclear Information and Resource Service (NIRS or the petitioner) and 37 co-petitioners. The petition was docketed by the NRC on February 17, 2012, and assigned Docket No. PRM-50-104. The petitioner requests that the NRC amend its regulations to expand the Emergency Planning Zones (EPZs) for nuclear power plants.

DATES:

Submit comments by July 16, 2012. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

ADDRESSES:

You may access information and comment submissions related to this petition for rulemaking, which the NRC possesses and is publicly available, by searching onhttp://www.regulations.govunder Docket ID NRC-2012-0046. You may submit comments by the following methods:

Please refer to Docket ID NRC-2012-0046 when contacting the NRC about the availability of information for this petition for rulemaking. You may access information related to this petition for rulemaking, which the NRC possesses and is publicly available, by the following methods:

•NRC's Agencywide Documents Access and Management System (ADAMS):You may access publicly available documents online in the NRC Library athttp://www.nrc.gov/reading-rm/adams.html.To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.”For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email topdr.resource@nrc.gov. The PRM is available in ADAMS under Accession No. ML12048B004.

Please include Docket ID NRC-2012-0046 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed. The NRC posts all comment submissions athttp://www.regulations.govas well as entering the comment submissions into ADAMS, and the NRC does not edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information in their comment submissions that they do not want to be publicly disclosed. Your request should state that the NRC will not edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

II. The Petitioner and the 37 Co-Petitioners

The PRM describes the petitioner and the 37 co-petitioners as “environmental and civic organizations with members who live within 100 miles of U.S. nuclear power plants and who are concerned that current NRC emergency planning requirements are not adequate to protect their health and safety in the event of an accident at the plant.”

The NIRS is a non-profit organization founded in 1978, which serves as a “national information and networking center for people concerned about nuclear power, radioactive waste, radiation and sustainable energy issues.” In addition, the NIRS is described as an organization that provides public education on issues such as deregulation of radioactive materials, new reactor licensing, transportation of radioactive waste, and nuclear reactor safety.

III. The Petition

The petitioner requests that the NRC amend Title 10 of the Code of Federal Regulations (10 CFR) 50.47, “Emergency Plans,” and Appendix E to 10 CFR Part 50, “Emergency Planning and Preparedness for Production and Utilization Facilities,” and include the modifications in 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants.” Specifically, the petitioner requests that (1) the Plume Exposure Pathway EPZ radius be expanded from a 10-mile radius to a 25-mile radius, (2) a new 50-mile radius Emergency Response Zone, with more limited requirements than the Plume Exposure Pathway EPZ, be established, (3) the Ingestion Pathway EPZ radius be expanded from a 50-mile radius to a 100-mile radius, and (4) the “emergency plans are tested to encompass initiating and/or concurrent natural disasters that may affect both accident progression and evacuation conduct.” The petitioner asserts that “the requested amendments are essential for the protection of public health and safety in light of the real-world experience of the Chernobyl and Fukushima disasters, which were more severe and affected a much larger geographical area than provided for in NRC regulations.”

The petitioner proposes the following revision to 10 CFR 50.47(c)(2) with regards to the plume exposure pathway EPZ:

A Plume Exposure Pathway zone shall consist of an area about 25 miles (40 km) in radius. Within this zone, detailed plans must be developed to provide prompt and effective evacuation and other appropriate protective measures, including conducting of biannual full-scale emergency evacuation drills. Sirens will be installed within this zone to alert the population of the need for evacuation. Transportation for elderly, prison and school populations shall be provided within this zone. Emergency shelters shall be located outside of the 25-mile zone.

The petitioner asserts that the expansion of the plume exposure pathway EPZ from a 10 mile radius to a 25 mile radius “would provide no new requirements other than expansion of the EPZ.”

50 Mile Emergency Response Zone

The petitioner proposes the following revision to 10 CFR 50.47(c)(2) with regards to an Emergency Response Zone:

The [emergency response zone] shall be about 50 miles in radius. Within this 50 mile zone, the licensee must identify evacuation routes for all residents within this zone and annually provide information to all residents within this zone about these routes and which they are supposed to take in the event of an emergency. The licensee must make basic pre-arrangements for potential transport of disabled/hospital/prison populations. Emergency centers for the public currently located less than 25 miles out shall be relocated to 25 miles or further out. Information shall be made available to the public within this zone through television, internet and radio alerts, text message notices, and other appropriate means of public communication.

The petitioner notes that this revision “would require measures be carried out between the new 25 mile Plume Exposure Pathway EPZ and a new Emergency Response Zone of about a 50 mile radius.” The petitioner states that the Plume Exposure Pathway EPZemergency evacuation requirements and biannual exercises are not required in the Emergency Response Zone. The petitioner further states “this new zone would provide a modest level of pre-planning that would enable rapid expansion of the 25 mile zone when necessary. Information regarding evacuation such as identification of evacuation routes and locations of emergency shelters in the event of a large scale disaster would be identified and would be provided to members of the public annually, and a limited number of other pre-arrangements would be made.”

100 Mile Ingestion Exposure Pathway Zone

The petitioner proposes the following revision to 10 CFR 50.47(c)(2) with regards to the ingestion pathway EPZ:

The ingestion pathway EPZ shall be about 100 miles in radius. In the event of a radioactive release, the deposition of radionuclides on crops, other vegetation, bodies of surface water and ground surfaces can occur. Measures will be implemented to protect the public from eating and drinking food and water that may be contaminated. Information shall be made available to the public within this zone through television and radio alerts, text message notices, and other appropriate means of public communication.

The petitioner states that “[t]he current Ingestion Exposure Pathway Zone exists to protect food, water and anything intended for human consumption within 50 miles of a nuclear power plant.” The petitioner further states “[g]iven that radiation can, and does, have far-reaching effects on food on a large radius, the Ingestion Pathway EPZ should be expanded.”

Drills and Exercises

The petitioner proposes amending 10 CFR 50.47(b)(14) with regards to drills and exercises by adding:

Within the emergency evacuation zone full scale drills and exercises will be conducted on a biannual basis. Every other exercise and drill shall include a scenario involving an initiating or concurrent regionally-appropriate natural disaster.

IV. The Petitioner's Bases

The petitioner states, “[w]ith the exception of a 2011 rule requiring licensees to use current U.S. census data to prepare evacuation time estimates (ETEs) and update them every 10 years, the NRC has made few significant improvements to its offsite emergency response regulations since they were promulgated in 1980.” The petitioner notes that “the NRC denied a set of petitions [submitted by the Citizens Task Force of Chapel Hill, et al.] to increase the size of the plume exposure pathway EPZ and the ingestion pathway EPZ” in 1990. The petitioner asserts that “[t]he Commission declined to revisit the assumptions about severe reactor accident risks that underlie its emergency planning regulations, concluding that the existing size of the EPZs was adequate to achieve `reasonable and feasible dose reduction' under the circumstances of each individual reactor site.” The petitioner's bases for the petition are further presented in the following paragraphs.

Chernobyl, September 11, and Fukushima Experiences

The petitioner cites reports and findings regarding the Chernobyl and Fukushima Dai-ichi accidents, and the September 11, 2001, terrorist attacks to support the petition. The petitioner asserts that “[t]he accident at Fukushima, added to the experience of the Chernobyl disaster, demonstrates that the 10 mile plume exposure pathway EPZ and the 50 mile ingestion pathway EPZ are inadequate to protect the public health and safety, both because severe accidents are clearly more likely than any government previously has estimated and because their effects are far more widespread.” The petitioner specifically cites the “Recommendations for Enhancing Reactor Safety in the 21st Century: The Near-Term Task Force Review of Insights from the Fukushima Dai-ichi Accident” (Fukushima Task Force Report, ADAMS Accession No. ML111861807), dated July 12, 2011. The petitioner notes that the Task Force formed to examine the Fukushima disaster “addressed the issues of protecting against accidents resulting from natural phenomena, mitigating the consequences of such accidents, and ensuring emergency preparedness” in the Fukushima Task Force Report. The petitioner also notes that the Task Force “made several recommendations, including strengthening and integrating onsite emergency response capabilities such as emergency operating procedures, severe accident management guidelines, and extensive damage mitigation guidelines.” The petitioner asserts that “the task force failed to make any recommendations on improving emergency response capabilities or expanding EPZ size, despite the Task Force's acknowledgement that it was necessary to evacuate Japanese residents up to and beyond a 20-kilometer (12-mile) area around Fukushima.” As the petitioner notes, the NRC is evaluating several Task Force recommendations related to emergency preparedness. More information about these activities is available through the NRC's public Web site athttp://www.nrc.gov/japan/japan-info.html.

The petitioner states that “[t]he NRC's existing emergency planning regulations (and the NRC's decision in Citizens Task Force of Chapel Hill) are based primarily on experience gained by the Three Mile Island accident and on NRC reactor safety studies conducted from the 1950s through the 1970s (for example, WASH-1400 and NUREG-1150) and are encapsulated in NUREG-0396.” The petitioner notes that in 2006, “the NRC began the State-of-the-Art Reactor Consequence Analyses (SOARCA) project to re-evaluate the `realistic consequences of a severe reactor accident.' ” The petitioner cites an October 2010 draft of the SOARCA report to support the petition. The petitioner asserts that “real-world experience at Fukushima trumps the computer modeling of SOARCA in any case and has presented the world—and the NRC—with an actual accident that exceeds postulated scenarios.” The petitioner continues by stating “[c]omputer models, simulations, evaluations of projected scenarios—all can be useful tools in evaluating the relative risks of complex systems like nuclear reactors. They can even be useful—in the absence of real-world information—in establishing regulations. But they exist primarily to generate postulated data in the absence of actual data—they are not a substitute for actual, real-world experience.”

The petitioner states that “[spent] fuel pools pose a serious and dangerous threat to the populations surrounding nuclear plants. Accidents could cause widespread contamination of highly radioactive materials.” The petitioner asserts that “[r]adiation exposure would be significantly worse if there were to be [a spent] fuel pool accident in addition to a reactor accident.” The petitioner makes the following statement regarding spent fuel pools: “In theory, this form of storage is meant to be temporary. But, because offsite storage of irradiated fuel is currently unavailable, high density storage of this material has been permitted to occur.” The petitioner also states, “Aside from concerns associated with the dense packing of a pool, the pools themselves are located outside ofthe primary containment which is designed to keep radiation which is released during an emergency event from escaping in to the environment. Because they are outside of the primary containment structure, they are more vulnerable than the core to natural disasters and terrorist attacks.”

Improved Understanding of Health Effects of Radiation

The petitioner states “[t]here is no `safe' dose of radiation, and as such the consideration of the effects of release of radiation should be given greater consideration.” The petitioner cites the 2006 National Research Council of the National Academy of Sciences Biological Effects of Ionizing Radiation (BEIR) VII Report and asserts the report confirms that “any exposure to radiation—including background radiation—increases a person's risk of developing cancer.” The petitioner states that “the NRC and licensees must recognize that their emergency response programs must be designed to protect not only against radiation levels that would cause acute effects, but also radiation levels that would exceed annual exposure limits * * *.” The petitioner asserts that “a government policy that implicitly states, as do NRC's existing emergency planning regulations, that radiation exposure levels higher than normally allowable—by orders of magnitude—are acceptable under emergency conditions, is a government policy that is unsupportable and without basis in reality.”

Particular Problems Associated With Pressure Suppression Containments

The petitioner asserts that “[t]he failure of a pressure suppression containment can result in widespread radioactive contamination of areas surrounding nuclear plants.” The petitioner states, “In Japan, hydrogen explosions occurred at (at least) three GE Mark I reactors using a pressure suppression system.” The petitioner also states, “There are 23 GE Mark I nuclear reactors—about one-quarter of the nation's reactors—essentially identical to the reactors that were destroyed at Fukushima, that are operational in the United States.” The petitioner makes the following statement: “Not only can the NRC no longer dismiss such accidents in the U.S., the NRC must instead assume that such accidents can occur in the U.S. and even, given the history of the nuclear age that large nuclear accidents are occurring at a much greater frequency than previously postulated, the NRC—at least for emergency planning purposes if nothing else—must assume that such accidentswilloccur in the U.S.”

Natural Disasters and Emergency Response Planning

The petitioner states that “[n]atural disasters have become increasingly prevalent in recent years causing concerns for nuclear reactors that are susceptible to various weather phenomena and disasters.” The petitioner asserts that “[c]urrent NRC emergency planning regulations do not reflect that natural disasters can both cause nuclear accidents and/or may occur concurrently with nuclear accidents.” The petitioner requests the following:

Emergency response planning for nuclear facilities must incorporate regionally-relevant initiating and concurrent natural disasters as a regular part of emergency exercises, to assure the most effective possible emergency response in the event of a nuclear accident triggered by or complicated by a natural disaster. For this reason, we propose that every other emergency exercise include a scenario that includes a regionally-relevant initiating and concurrent natural disaster. By “regionally relevant” we mean that plans should be made and exercises undertaken for the type of natural disaster most likely to affect a given licensee site * * *. However, for areas that may be affected by more than one type of natural disaster * * * each exercise should include a different regionally relevant scenario.

This document contains proposed regulations relating to the disclosure of return information under section 6103(l)(21) of the Internal Revenue Code, as enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010. The regulations define certain terms and prescribe certain items of return information in addition to those items prescribed by statute that will be disclosed, upon written request, under section 6103(l)(21) of the Internal Revenue Code.

DATES:

Written (including electronic) comments must be received by July 30, 2012. Outlines of topics to be discussed at the public hearing scheduled for Friday, August 31, 2012, must be received by July 30, 2012.

Concerning the proposed regulations, Steven Karon, (202) 622-4570; concerning the submission of comments, the public hearing, and to be placed on the building access list to attend the public hearing, Olumafunmilayo Taylor, (202) 622-7180 (not toll-free numbers).

SUPPLEMENTARY INFORMATION:Background

Beginning in 2014, under the Patient Protection and Affordable Care Act, Public Law 111-148 (124 Stat. 119 (2010)), and the Health Care and Education Reconciliation Act of 2010, Public Law 111-152 (124 Stat. 1029 (2010)) (collectively, the Affordable Care Act), Affordable Insurance Exchanges (Exchanges) will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options (qualified health plans, or QHPs) on the basis of price, quality, and other factors, and to purchase such coverage. A Federally-facilitated Exchange will operate on behalf of States electing not to pursue a State-based Exchange. In general, a QHP is a health plan offered by a health insurance issuer that meets minimum standards in the law and set by an Exchange.

Qualified individuals and small employers will be able to purchase private health insurance through Exchanges. Certain individuals who choose to obtain coverage through an Exchange will be eligible to qualify for a new premium tax credit and/or cost-sharing reductions established to help make the purchase of insurance more affordable.

Section 1411(a) of the Affordable Care Act directs the Secretary of the Department of Health and Human Services (HHS) to establish a program under which Exchanges will determine whether individuals are eligible to enroll in QHPs through the Exchange, and whether they are eligible for advance payments of the premium tax credit and cost-sharing reductions. Section 1412 of the Affordable Care Act directs the Secretary of HHS to establish a program for determining eligibility for advance payments of the premium tax credit and cost-sharing reductions that may be paid directly to an insurance company on behalf of a taxpayer. Eligibility for advance payments, like eligibility for the premium tax credit itself, is based in part on the household income of the individual who will claim the credit. Household income is defined in section 36B(d)(2) as the total of the modified adjusted gross incomes (MAGI) of the taxpayer claiming the premium tax credit and those other individuals for whom the taxpayer was allowed a deduction under section 151 and who were required to file a tax return.

Section 1413(a) of the Affordable Care Act directs the Secretary of HHS to establish a system under which an individual may submit a single, streamlined application to apply for specified insurance affordability programs (that is, the premium tax credit under section 36B, cost-sharing reductions under section 1402 of the Affordable Care Act, Medicaid, the Children's Health Insurance Program (CHIP), and a State's basic health program, if applicable, under section 1331 of the Affordable Care Act). The system must be compatible with the processes set up to determine eligibility for advance payments of the premium tax credit and cost-sharing reductions. Where an individual seeking eligibility for any of these insurance affordability programs is found to be eligible for Medicaid or CHIP, the individual is enrolled in that program. If an individual is not eligible for one of these programs, the Exchange will make the determination (or provide for HHS to make the determination) as to the individual's eligibility for advance payments of the premium tax credit under section 36B and for cost-sharing reductions, and the amount of any advance payments. Under section 1412(c)(2) of the Affordable Care Act, advance payments are made monthly (or on another periodic basis as HHS may provide) directly to the issuer of the qualified health plan in which the individual enrolls.

Section 1411(b)(3) of the Affordable Care Act requires that individuals seeking an eligibility determination for advance payments of the premium tax credit or for cost-sharing reductions provide the Exchange with information regarding their household income and family size to demonstrate that they meet the income-based eligibility requirements. However, section 1411(c)(4)(B) of the Affordable Care Act grants the Secretary of HHS authority to modify the methods used for the verification of information if the Secretary of HHS determines those modifications would reduce the administrative costs and burdens on individuals seeking coverage through an Exchange. The section explicitly gives the Secretary of HHS authority to change the manner in which Exchanges determine eligibility for advance payments of the premium tax credit or for cost-sharing reductions, so long as any applicable requirements under section 6103 of the Internal Revenue Code with respect to the confidentiality, disclosure, maintenance and use of return information would still be met. Section 1411(g) of the Affordable Care Act further provides that individuals will be required to provide only the minimum amount of information needed to authenticate an individual's identity and to determine the individual's eligibility for, and amount of, advance payments of the premium tax credit or cost-sharing reductions.

In proposing regulations in theFederal Registeron August 17, 2011, the Secretary of HHS concluded that a less burdensome and more reasonable eligibility process would not require an individual to provide an Exchange with specific income-related information, such as the individual's MAGI (76 FR 51202 at 51214). Accordingly, the Secretary of HHS promulgated final regulations published in theFederal Registeron March 27, 2012 (77 FR 18310), limiting the information an individual needs to provide to an Exchange for purposes of income verification and allowing the Exchange to solicit information from the IRS through HHS with respect to the individual and his family members whose names and social security numbers, or adoption taxpayer identification numbers, are provided. The regulations also provide guidance on the eligibility determination process for enrollment in a QHP, advance payments of the premium tax credit and cost-sharing reductions, and other insurance affordability programs. Additionally, the Secretary of HHS promulgated final regulations published in theFederal Registeron March 23, 2012 (77 FR 17144) that provide revised eligibility rules for Medicaid. The Treasury Department and the IRS proposed regulations in theFederal Registeron August 17, 2011 (76 FR 51202) to implement the new premium tax credit.

Section 6103(l)(21) permits the disclosure of return information to assist Exchanges in performing certain functions set forth in section 1311 of the Affordable Care Act for which income verification is required (including determinations of eligibility for the insurance affordability programs described in the Affordable Care Act), as well as to assist State agencies administering a State Medicaid program under title XIX of the Social Security Act, CHIP under title XXI of the Social Security Act, or a basic health program under section 1331 of the Affordable Care Act (if applicable). Section 6103(l)(21) identifies specific items of return information that will be disclosed and permits the disclosure of such other items prescribed by regulation that might indicate whether an individual is eligible for the premium tax credit under section 36B or cost-sharing reductions under section 1402, and the amount thereof. After an individual submits an application for financial assistance in obtaining health coverage provided pursuant to Title I, subtitle E, of the Affordable Care Act (“the application”) to an Exchange or State agency, the IRS will disclose the available items of return information described under section 6103(l)(21)(A) to HHS. Pursuant to section 6103(l)(21)(B), HHS will then disclose the information to the Exchange or State agency that is processing the application.

As a condition for receiving return information under section6103(l)(21)(A) and (B), each receiving entity (that is, HHS, the Exchanges, and State agencies that administer Medicaid, CHIP, or basic health plans, and their respective contractors) is required to adhere to the safeguards established under section 6103(p)(4). Final HHS regulations published in theFederal Registeron March 27, 2012 (77 FR at 18446, 18450) state that to be certified by HHS an Exchange must demonstrate readiness to meet the section 6103 confidentiality requirements with respect to the items of return information the Exchange will receive. As described in section 6103(l)(21)(C), each receiving entity may then use the return information received under sections 6103(l)(21)(A) and (B) only for the purposes of, and to the extent necessary in, establishing eligibility for participation in the Exchange, verifying the appropriate amount of any advance payments of the premium tax credit or cost-sharing reductions, and determining eligibility for participation in a State Medicaid program, CHIP, or basic health program under section 1331 of the Affordable Care Act.

Under section 6103(l)(21)(A), the IRS will disclose to HHS (including its contractor(s)) certain items of return information, as enumerated in the statute or by regulation, for any relevant taxpayer. For purposes of these regulations, a relevant taxpayer is defined to be any individual listed, by name and social security number or adoption taxpayer identification number (“taxpayer identity information”), on the application whose income may bear upon a determination of the eligibility of an individual for an insurance affordability program. For each relevant taxpayer, section 6103(l)(21) explicitly authorizes the disclosure of the following items of return information from the reference tax year: Taxpayer identity information, filing status, the number of individuals for which a deduction under section 151 was allowed (“family size”), MAGI, and the taxable year to which any such information relates or, alternatively, that such information is not available. The “reference tax year” is the first calendar year or, where no return information is available in that year the second calendar year, prior to the submission of the application. MAGI is defined under section 36B as the taxpayer's adjusted gross income defined under section 62, increased by three components: (1) Any amount excluded from gross income under section 911, (2) any amount of interest received or accrued by the taxpayer during the taxable year that is exempt from tax, and (3) the amount of social security benefits of the taxpayer excluded from gross income under section 86 for the tax year.

In some situations, the IRS will be unable to calculate MAGI. While uncommon, for certain relevant taxpayers who receive nontaxable social security benefits, the IRS may not have complete information from which to determine the amount of those benefits. If the IRS has information indicating that a relevant taxpayer received nontaxable social security benefits, but is unable to determine the amount of those benefits, the IRS will provide the aggregate amount of the other components used to calculate the relevant taxpayer's MAGI, as well as information indicating that the amount of nontaxable social security benefits must still be taken into account to determine MAGI. Similarly, where MAGI is not available, the IRS will disclose the adjusted gross income, as well as information indicating that the other components of MAGI must still be taken into account to determine MAGI. Because the Affordable Care Act and HHS's final regulations (77 FR at 18456-18458) require that Exchanges use alternative means to verify income where information is not available from the IRS, these explanatory items may assist an Exchange in determining an individual's eligibility for, and amount of, any advance payment of the premium tax credit or cost-sharing reductions.

The proposed regulations further provide that, in certain instances, where some or all of the items of return information prescribed by statute or regulation is unavailable, the IRS will provide information indicating why the particular item of return information is not available. Where an individual jointly filed with a spouse who is not a relevant taxpayer (that is, that spouse is not included on the application), the IRS will not disclose MAGI from the joint return because it cannot be appropriately allocated between the two spouses. Instead, the IRS will disclose that a joint return had been filed. This additional information may help individuals correct any errors or understand why they need to pursue alternative routes to verify their income. This information, therefore, also can assist Exchanges in determining whether an individual is eligible for advance payments of the premium tax credit or cost-sharing reductions.

Additionally, the IRS may have information in its records indicating that a relevant taxpayer had been a victim of identity theft or that a relevant taxpayer has been reported as deceased. The proposed regulations provide that the IRS will disclose that, although a return for that taxpayer is on file, the information described under section 6103(l)(21) is not being provided because IRS records suggest that the Exchange should take additional steps to authenticate the identities of the relevant taxpayers and may need to use alternate means for income verification.

Where an individual who is listed as a dependent on the application (for the tax year in which the premium tax credit will be claimed) filed a return in the reference tax year but did not have a tax filing requirement for that year (based upon the return filed), the IRS will provide information indicating the dependent listed did not have a filing requirement because the information is relevant to the Exchange's computation of household income.

The final regulations issued by HHS provide that advance payments of the premium tax credit will not be permitted where the relevant taxpayer has received advance payments in the reference tax year and failed to file a return reconciling the advance payments with the actual premium tax credit. (77 FR at 18453). Therefore, these proposed regulations provide that the IRS will disclose to HHS that a relevant taxpayer who received an advance payment of a premium tax credit in the reference tax year did not file a return reconciling the advance payments with any premium tax credit available.

Special Analyses

It has been determined that this Notice of Proposed Rule Making is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It has also been determined that, because the regulations proposed do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, this notice of proposed rulemaking will be submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

Comments and Public Hearing

The Treasury Department and the IRS request comments on all aspects of the proposed rules. A public hearing has been scheduled for August 31, 2012, at 10:00 a.m., in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue NW., Washington, DC. Due to building security procedures, visitors must enter at the Constitution Avenue entrance. Inaddition, all visitors must present photo identification to enter the building. Because of access restrictions, visitors will not be admitted beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see theFOR FURTHER INFORMATION CONTACTsection of this preamble.

The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing must submit written or electronic comments and an outline of the topics to be discussed and the time to be devoted to each topic (a signed original and eight (8) copies) by July 30, 2012. A period of 10 minutes will be allotted to each person for making comments. An agenda showing the scheduling of the speakers will be prepared after the deadline for receiving outlines has passed. Copies of the agenda will be available free of charge at the hearing.

Drafting Information

The principal author of the regulations is Steven L. Karon of the Office of the Associate Chief Counsel, Procedure and Administration.

Paragraph 1.The authority citation for part 301 is amended by adding the entry for § 301.6103(l)(21) to read in part as follows:

Authority:

26 U.S.C. 7805 * * *

Section 301.6103(l)(21)-(1) also issued under 26 U.S.C. 6103(l)(21) and 6103(q).

Par. 2.Add § 301.6103(l)(21)-1 to read as follows:

§ 301.6103(l)(21)-1Disclosure of return information to the Department of Health and Human Services to carry out eligibility requirements for health insurance affordability programs.

(a)General rule.Pursuant to the provisions of section 6103(l)(21)(A) of the Internal Revenue Code, officers and employees of the Internal Revenue Service will disclose, upon written request, for each relevant taxpayer on a single application those items of return information that are described under section 6103(l)(21)(A) and paragraphs (a)(1) through (6) of this section, for the reference tax year, as applicable, to officers, employees and contractors of the Department of Health and Human Services, solely for purposes of, and to the extent necessary in, establishing an individual's eligibility for participation in an Exchange established under the Patient Protection and Affordable Care Act, including eligibility for, and determining the appropriate amount of, any premium tax credit under section 36B or cost-sharing reduction under section 1402 of the Patient Protection and Affordable Care Act, or determining eligibility for the State programs described in section 6103(l)(21)(A).

(1) With respect to each relevant taxpayer for the reference tax year where the amount of social security benefits not included in gross income under section 86 of the Internal Revenue Code of that relevant taxpayer is unavailable:

(i) The aggregate amount of the following items of return information—

(B) Any amount excluded from gross income under section 911 of the Internal Revenue Code; and

(C) Any amount of interest received or accrued by the taxpayer during the taxable year which is exempt from tax.

(ii) Information indicating that the amount of social security benefits not included in gross income under section 86 of the Internal Revenue Code is unavailable.

(2) Adjusted gross income, as defined by section 62 of the Internal Revenue Code, of a relevant taxpayer for the reference tax year, in circumstances where the modified adjusted gross income (MAGI), as defined by section 36B(d)(2)(B) of the Internal Revenue Code, of that relevant taxpayer is unavailable, as well as information indicating that the components of MAGI other than adjusted gross income must be taken into account to determine MAGI;

(3) Information indicating that certain return information of a relevant taxpayer is unavailable for the reference tax year because the relevant taxpayer jointly filed a U.S. Individual Income Tax Return for that year with a spouse who is not a relevant taxpayer listed on the same application;

(4) Information indicating that, although a return for an individual identified on the application as a relevant taxpayer for the reference tax year is available, return information is not being provided because of possible authentication issues with respect to the identity of the relevant taxpayer;

(5) Information indicating that a relevant taxpayer who is identified as a dependent for the tax year in which the premium tax credit under section 36B of the Internal Revenue Code would be claimed, did not have a filing requirement for the reference tax year based upon the U.S. Individual Income Tax Return the relevant taxpayer filed for the reference tax year; and

(6) Information indicating that a relevant taxpayer who received advance payments of the premium tax credit in the reference tax year did not file a tax return for the reference tax year reconciling the advance payments of the premium tax credit with any premium tax credit under section 36B of the Internal Revenue Code available for that year.

(b)Relevant taxpayer defined.For purposes of paragraph (a) of this section, a relevant taxpayer is defined to be any individual listed, by name and social security number or adoption taxpayer identification number, on an application submitted pursuant to Title I, Subtitle E, of the Patient Protection and Affordable Care Act, whose income may bear upon a determination of any advance payment of any premium tax credit under section 36B of the Internal Revenue Code, cost-sharing reduction under section 1402 of the Patient Protection and Affordable Care Act, or eligibility for any program described in section 6103(l)(21)(A) of the Internal Revenue Code.

(c)Reference tax year defined.For purposes of section 6103(l)(21)(A) of the Internal Revenue Code and this section, the reference tax year is the first calendar year or, where no return information is available in that year, the second calendar year, prior to the submission of an application pursuant to Title I, Subtitle E, of the Patient Protection and Affordable Care Act.

(d)Effective/applicability date.This section applies to disclosures to the Department of Health and Human Services on or after these proposed regulations are published as final regulations in theFederal Register.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to amend the regulations setting forth the standards of identity for distilled spirits to include “Cachaça” as a type of rum and as a distinctive product of Brazil. This proposal follows requests received from the Government of Brazil and subsequent discussions with the Office of the United States Trade Representative. TTB invites comments on this proposed amendment to the TTB regulations.

DATES:

Comments must be received on or before June 29, 2012.

ADDRESSES:

You may send comments on this notice to one of the following addresses:

•http://www.regulations.gov:To submit comments via the Internet, use the comment form for this notice as posted within Docket No. TTB-2012-0002 at “Regulations.gov,” the Federal e-rulemaking portal;

See the Public Participation section of this notice for specific instructions and requirements for submitting comments, and for information on how to request a public hearing.

You may view copies of this notice, selected supporting materials, and any comments TTB receives about this proposal within Docket No. TTB-2012-0002 athttp://www.regulations.gov.A link to this Regulations.gov docket is posted on the TTB Web site athttp://www.ttb.gov/regulations_laws/all_rulemaking.shtmlunder Notice No. 127. You also may view copies of this notice, all supporting materials, and any comments TTB receives about this proposal by appointment at the TTB Information Resource Center, 1310 G Street NW., Washington, DC 20005. Please call 202-453-2270 to make an appointment.

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), codified in the United States Code at 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations relating to the packaging, marking, branding, labeling, and size and fill of containers of alcohol beverages that will prohibit consumer deception and provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01 (Revised), dated January 21, 2003, to the TTB Administrator to perform the functions and duties in the administration and enforcement of this law. Regulations implementing the provisions of section 105(e) as they relate to distilled spirits are set forth in part 5 of title 27 of the Code of Federal Regulations (27 CFR part 5).

Classes and Types of Spirits

The TTB labeling regulations require that the class and type of distilled spirits appear on the product's brand label. See 27 CFR 5.32(a)(2) and 5.35. Those regulations provide that the class and type must be stated in conformity with § 5.22 of the TTB regulations (27 CFR 5.22) if defined therein. Otherwise, the product must be designated in accordance with trade and consumer understanding thereof, or, if no such understanding exists, by a distinctive or fanciful name, and, in either case (with limited exceptions), followed by a truthful and adequate statement of composition.

Section 5.22 establishes standards of identity for distilled spirits products and categorizes these products according to various classes and types. As used in § 5.22, the term “class” refers to a general category of spirits, such as “whisky” or “brandy.” Currently, there are 12 different classes of distilled spirits recognized in § 5.22, including whisky, rum, and brandy. The term “type” refers to a subcategory within a class of spirits. For example, “Cognac” is a type of brandy, and “Canadian whisky” is a type of whisky.

Classification of Cachaça

“Cachaça” is a term recognized by the Brazilian Government as a designation for a Brazilian distilled spirits product made from sugar cane. Cachaça products are generally classified as rums under the terms of TTB's current labeling regulations. The standard of identity for rum is set forth in § 5.22(f) as follows:

Class 6; rum.“Rum” is an alcoholic distillate from the fermented juice of sugar cane, sugar cane syrup, sugar cane molasses, or other sugar cane by-products, produced at less than 190° proof in such manner that the distillate possesses the taste, aroma and characteristics generally attributed to rum, and bottled at not less than 80° proof; and also includes mixtures solely of such distillates.

The above standard does not currently provide for any subcategories or “types” of rum.

In some instances, products identified by importers as Cachaça have been manufactured using a small quantity of corn or corn syrup in the fermentation process. Since these products do not meet the standard for rum as described at § 5.22(f), TTB has required the labeling of these products as distilled spirit specialty products in accordance with § 5.35. In some instances, these products have been labeled with the fanciful name “Cachaça,” followed by a truthful and adequate statement of composition.

2001 Brazilian Petition

By letter dated April 30, 2001, the Embassy of the Government of Brazil submitted a petition to the Bureau of Alcohol, Tobacco and Firearms (ATF) in which it requested that ATF amend its regulations to recognize the Brazilian distilled spirits product known as “Cachaça” as a distinctive product of Brazil.

The Brazilian Embassy stated that Cachaça is known worldwide as a Brazilian product and that Brazil has been a supplier of Cachaça to the United States for many decades. After preliminary discussions with the Brazilian Embassy, no further action was taken with regard to the request.

2006 Brazilian Petition

In a petition dated March 6, 2006, the Brazilian Embassy requested that TTB amend its regulations to providerecognition of Cachaça as a distinctive product of Brazil.

Among other things, the Embassy noted Brazilian Decree No. 4851, of October 2, 2003, which defines “Cachaça” as “the typical and exclusive designation of the sugar cane aguardente produced in Brazil, with an alcohol content of 38 to 48 percent by volume at 20 degrees Celsius, obtained from the distillation of the fermented must of sugar cane with specific sensory characteristics, to which up to six grams of sugar per liter may be added, expressed in terms of sucrose.”

In addition, following discussions between officials of Brazil and the Office of the United States Trade Representative (USTR), and after consultations between USTR, and TTB, the United States Trade Representative and Brazil's Minister of Development, Industry, and Foreign Trade signed an agreement on April 9, 2012, setting out a procedure that could lead each party to recognize certain distinctive distilled spirits produced in the other party's territory, including Cachaça. The agreement provides in part that if, following the publication of a notice of proposed rulemaking, the United States publishes a final rule that provides, among other things, that Cachaça is a type of rum that is a distinctive product of Brazil, then Brazil, within 30 days thereafter, will recognize Bourbon Whiskey and Tennessee Whiskey as distinctive products of the United States.

In addition to the petition from the Brazilian Government and advice from USTR, TTB has received a number of essentially identical letters from private parties supporting the recognition of Cachaça as a distinctive type of spirit.

TTB Regulatory Proposal

TTB considers that it is appropriate to recognize Cachaça as a distinctive product of Brazil. Therefore, this notice proposes to recognize Cachaça as a type within the class designation rum that would be recognized as a distinctive product of Brazil, manufactured in Brazil in compliance with the laws of Brazil regulating the manufacture of Cachaça for consumption in that country. Thus, the product may simply be labeled as “Cachaça” without the term “rum” on the label, just as a product labeled with the type designation “Cognac” is not required to also bear the class designation “brandy.”

The proposed type description will not include as “Cachaça” any spirits that use corn or corn syrup in the fermentation process. TTB has confirmed with the Brazilian Government that the Brazilian standard for Cachaça would not allow for the use of corn or corn syrup in the fermentation process. As such, under the terms of the proposed text set forth in this document, distilled spirits that use any corn or corn syrup in the fermentation process would not meet the proposed standard for “Cachaça” because they are not manufactured in compliance with the laws of Brazil regulating the manufacture of Cachaça for consumption in that country. Such products would not be entitled to be labeled as Cachaça.

The Brazilian standard allows products designated as Cachaça to have an alcohol content ranging from 38 to 48 percent alcohol by volume. However, since the standard proposed in this document would identify Cachaça as a type of rum, and the United States standard requires that rum must be bottled at not less than 40 percent alcohol by volume, or 80 degrees proof, any “Cachaça” imported into the United States would have to conform to this minimum bottling proof requirement. A product that is bottled at below 40 percent alcohol by volume would fall outside this class and type designation. Depending on the way that such a product is manufactured, it could be labeled as a “diluted Cachaça” or a distilled spirits specialty product bearing a statement of composition.

Public ParticipationComments Invited

TTB invites comments from interested members of the public on this proposed rule, including on whether the proposed amendment would have an adverse impact on owners of U.S. trademarks and on the extent to which distilled spirits labeled as “Cachaça” are produced outside Brazil. Although information currently before TTB suggests that all distilled spirits currently sold in the United States with “Cachaça” on the label are produced in Brazil, comments on the extent of production outside of Brazil will assist TTB in determining whether Cachaça should be recognized as a distinctive product of Brazil.

Submitting Comments

You may submit comments on this notice by using one of the following three methods:

•Federal e-Rulemaking Portal:You may send comments via the online comment form associated with this notice in Docket No. TTB-2012-0002 on “Regulations.gov,” the Federal e-rulemaking portal, athttp://www.regulations.gov.A link to this Regulations.gov docket is available under Notice No. 127 on the TTB Web site athttp://www.ttb.gov/regulations_laws/all_rulemaking.shtml.Supplemental files may be attached to comments submitted via Regulations.gov. For information on how to use Regulations.gov, click on the site's Help or FAQ tabs.

If you are commenting on behalf of an association, business, or other entity, your comment must include the entity's name as well as your name and position title. If you comment via Regulations.gov, please include the entity's name in the “Organization” blank of the comment form. If you comment via postal mail, please submit your entity's comment on letterhead.

You may also write to the Administrator before the comment closing date to ask for a public hearing. The Administrator reserves the right to determine whether to hold a public hearing.

Confidentiality

All submitted comments and attachments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider to be confidential or inappropriate for public disclosure.

Public Disclosure

On the Federal e-rulemaking portal, Regulations.gov, TTB will post, and you may view, copies of this notice, selected supporting materials, and any electronic or mailed comments we receive about this proposal. A link to the Regulations.gov docket containing this notice, any posted supporting materials, and the comments received on this proposal is available on the TTB Web site athttp://www.ttb.gov/regulations_laws/all_rulemaking.shtmlunder Notice No. 127. You may also reach the relevant docket through the Regulatons.gov search page athttp://www.regulations.gov.For informationon how to use Regulations.gov, click on the site's Help or FAQ tabs.

All posted comments will display the commenter's name, organization (if any), city, and State, and, in the case of mailed comments, all address information, including email addresses. We may omit voluminous attachments or material that we consider unsuitable for posting.

You also may view copies of this notice, the related petitions, any other supporting materials, and any electronic or mailed comments we receive about this proposal by appointment at the TTB Information Resource Center, 1310 G Street NW., Washington, DC 20005. You may also obtain copies at 20 cents per 8.5- × 11-inch page. Contact our information specialist at the above address or by telephone at 202-453-2270 to schedule an appointment or to request copies of comments or other materials.

Regulatory Flexibility Act

We certify that this proposed amendment, if adopted, would not have a significant economic impact on a substantial number of small entities. The proposed amendment only amends the standards of identity for rum at 27 CFR 5.22(f) and does not impose any new reporting, recordkeeping, or other administrative requirement. Therefore, no regulatory flexibility analysis is required.

Executive Order 12866

It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required.

Drafting Information

Christopher M. Thiemann of the Regulations and Rulings Division prepared this notice.

For the reasons discussed in the preamble, TTB proposes to amend 27 CFR part 5, as follows:

PART 5—LABELING AND ADVERTISING OF DISTILLED SPIRITS

1. The authority citation for part 5 continues to read as follows:

Authority:

26 U.S.C. 5301, 7805, 27 U.S.C. 205.

2. Section 5.22 is amended by revising paragraph (f) to read as follows:

§ 5.22The standards of identity.

(f)Class 6; rum.“Rum”is an alcoholic distillate from the fermented juice of sugar cane, sugar cane syrup, sugar cane molasses, or other sugar cane by-products, produced at less than 190° proof in such manner that the distillate possesses the taste, aroma, and characteristics generally attributed to rum, and bottled at not less than 80° proof; and also includes mixtures solely of such distillates.

(1) “Cachaça”is a type of rum that is a distinctive product of Brazil, manufactured in Brazil in compliance with the laws of Brazil regulating the manufacture of Cachaça for consumption in that country. The word “Cachaça” may be spelled with or without the diacritic mark (i.e.,“Cachaça” or “Cachaca”).

EPA is proposing to approve revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from wine storage. We are approving a local rule that regulates these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

DATES:

Any comments must arrive by May 30, 2012.

ADDRESSES:

Submit comments, identified by docket number [DOCKET NUMBER], by one of the following methods:

Instructions:All comments will be included in the public docket without change and may be made available online atwww.regulations.gov,including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted throughwww.regulations.govor email.www.regulations.govis an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send email directly to EPA, your email address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

Docket:Generally, documents in the docket for this action are available electronically atwww.regulations.govand in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed atwww.regulations.gov,some information may be publicly available only at the hard copy location (e.g., copyrighted material, large maps), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in theFOR FURTHER INFORMATION CONTACTsection.

FOR FURTHER INFORMATION CONTACT:

Lily Wong, EPA Region IX, (415) 947-4114,wong.lily@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document, “we,” “us” and “our” refer to EPA.

Table of ContentsI. The State's SubmittalA. What rule did the State submit?B. Are there other versions of this rule?C. What is the purpose of the submitted rule revision?II. EPA's Evaluation and ActionA. How is EPA evaluating the rule?B. Does the rule meet the evaluation criteria?C. Public Comment and Final ActionIII. Statutory and Executive Order ReviewsI. The State's SubmittalA. What rule did the State submit?

Table 1 lists the rule addressed by this proposal with the date that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB).

On December 22, 2011, EPA determined that the November 18, 2011 submittal for SJVUAPCD Rule 4694 met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

B. Are there other versions of this rule?

There are no previous versions of Rule 4694 in the SIP. CARB originally submitted Rule 4694 to EPA on June 16, 2006, and EPA will refer to that version of the rule as the “originally submitted Rule 4694.” While we can act on only the most recently submitted version, we have reviewed materials provided with previous submittals.

On August 18, 2011, SJVUAPCD adopted Resolution No. 11-08-20 in which the Governing Board approved “* * * an amendment to its earlier SIP submittal of Rule 4694 (Wine Fermentation and Storage Tanks), as set forth in the strike-out version of the Rule, attached hereto and incorporated herein by this reference.” The Resolution also stated that the strike-out text represents SJVUAPCD's withdrawal of those provisions for consideration by EPA for SIP approval. This revised SIP submittal of Rule 4694 was submitted to EPA from CARB on November 18, 2011, and will be referred to in this notice as the “amended submittal of Rule 4694.”

C. What is the purpose of the submitted rule revision?

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires States to submit regulations that control VOC emissions. The amended submittal of Rule 4694 applies to wineries that store fermented wine in bulk containers (i.e., storage tanks), and requires that the stored wine be maintained at or below 75 degrees Fahrenheit and the storage tanks to be equipped with pressure-vacuum relief valves. EPA's technical support document (TSD) has more information about this rule.

II. EPA's Evaluation and ActionA. How is EPA evaluating the rule?

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source in nonattainment areas (see sections 182(a)(2) and (b)(2)), and must not relax existing requirements (see sections 110(l) and 193). The SJVUAPCD regulates an ozone nonattainment area (see 40 CFR part 81). Because Rule 4694 regulates major sources, Rule 4694 must fulfill RACT.

Guidance and policy documents that we use to evaluate enforceability and RACT requirements consistently include the following:

3. State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).

B. Does the rule meet the evaluation criteria?

We believe this rule is consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. SJVUAPCD evaluated RACT for emissions from wine fermentation and storage.

While EPA has not developed a CTG document for wine fermentation and storage, this category includes sources that emit more than 10 tons per year of VOCs (i.e., major sources). Consequently, Rule 4694 must fulfill RACT.

SJVUAPCD evaluated six technologies for controlling emissions from wine fermentation and wine storage. SJVUAPCD concluded that while the control technologies were technologically feasible, they were not demonstrated to be economically feasible at this time. Furthermore, SJVUAPCD determined that there are no control technologies currently achieved in practice in this source category. Consequently, SJVUAPCD concluded that there are no reasonably available control technologies for wine fermentation and wine storage.

EPA agrees with SJVUAPCD's conclusion that emission controls have not been demonstrated in practice for wine fermentation emissions on the scale of the affected facilities. Therefore EPA agrees that RACT for wine fermentation emissions at this time is no controls.

For wine storage emissions, SJVUAPCD concluded that the six control technologies as well as the use of pressure-vacuum relief valves and temperature control was not cost effective and that RACT for wine storage is also no controls. We note however that the amended submittal of Rule 4694 requires pressure-vacuum relief valves and temperature control, and EPA is not aware of reasonably available control technology that might be beyond this control technology. EPA therefore concludes that the amended submittal of Rule 4694 meets or exceeds RACT for emissions from wine storage. The TSD has more information on our evaluation.

C. Public Comment and Final Action

Because EPA believes the submitted rule fulfills all relevant requirements, we are proposing to fully approve it as described in section 110(k)(3) of the Act. We will accept comments from the public on this proposal for the next 30 days. Unless we receive convincing new information during the comment period, we intend to publish a final approval action that will incorporate this rule into the federally enforceable SIP.

On January 10, 2012, EPA partially approved and partially disapproved the RACT SIP submitted by California on June 18, 2009 for the SJV extreme ozone nonattainment area (2009 RACT SIP), based in part on our conclusion that the State had not fully satisfied CAA section182 RACT requirements for wine fermentation and storage tank operations. See 77 FR 1417, 1425 (January 10, 2012). Final approval of Rule 4694 would satisfy California's obligation to implement RACT under CAA section 182 for this source category for the 1-hour ozone and 1997 8-hour ozone NAAQS.

III. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this proposed action does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.List of Subjects in 40 CFR Part 52

This document proposes to expand the scope of this proceeding to propose a set of technical rules for the operation of unlicensed level probing radars (LPR) in several frequency bands. LPR devices are low-power radars that measure the level (relative height) of various substances in man-made or natural containments. In open-air environments, LPR devices may be used to measure levels of materials such as coal piles or water basin levels. An LPR device also may be installed inside an enclosure,e.g.,a tank made of materials such as steel or fiberglass and commonly referred to as a tank level probing radar (TLPR) that could be filled with liquids or granulates. During the pendency of the rulemaking proceeding, but outside this proceeding, the Commission received waiver requests and other inquiries regarding outdoor use on additional frequencies under existing rules for unlicensed devices. To address the apparent need for a comprehensive and consistent approach to LPR devices, the Commission is proposing in this FNPRM rules that would apply to the operation of LPR devices installed in both open-air environments and inside storage tanks in the following frequency bands: 5.925-7.250 GHz, 24.05-29.00 GHz, and 75-85 GHz.

DATES:

Comments must be filed on or before May 30, 2012, and reply comments must be filed on or before June 29, 2012.

For detailed instructions for submitting comments and additional information on the rulemaking process, see theSUPPLEMENTARY INFORMATIONsection of this document.

SUPPLEMENTARY INFORMATION:

This is a summary of the Commission's FurtherNotice of Proposed Rule Making,ET Docket No. 10-23, FCC 12-34, adopted March 26, 2012, and released March 27, 2012. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room, CY-B402, Washington, DC 20554. The full text may also be downloaded at:www.fcc.gov.

Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).See Electronic Filing of Documents in Rulemaking Proceedings,63 FR 24121 (1998).

Electronic Filers:Comments may be filed electronically using the Internet byaccessing the ECFS:http://fjallfoss.fcc.gov/ecfs2/.

Paper Filers:Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St., SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed ofbeforeentering the building.

Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.

1. In the Further Notice of Proposed Rule Making (FNPRM), the Commission expands the scope of this proceeding to propose a set of technical rules for the operation of unlicensed level probing radars (LPR) in several frequency bands. LPR devices are low-power radars that measure the level (relative height) of various substances in man-made or natural containments. In open-air environments, LPR devices may be used to measure levels of materials such as coal piles or water basin levels. An LPR device also may be installed inside an enclosure,e.g.,a tank made of materials such as steel or fiberglass and commonly referred to as a tank level probing radar (TLPR) that could be filled with liquids or granulates. In theNotice of Proposed Rule Making and Order(Notice and Order), 75 FR 9850, March 4, 2010, in this proceeding, the Commission proposed rules applicable only to TLPR devices for operation in the 77-81 GHz band inside steel and concrete tanks, as that was the use requested by the initial proponents. During the pendency of the rulemaking proceeding, but outside this proceeding, the Commission received waiver requests and other inquiries regarding outdoor use on additional frequencies under existing part 15 rules for unlicensed devices. To address the apparent need for a comprehensive and consistent approach to LPR devices, the Commission proposed in this FNPRM rules that would apply to the operation of LPR devices installed in both open-air environments and inside storage tanks in the following frequency bands: 5.925-7.250 GHz, 24.05-29.00 GHz, and 75-85 GHz.

2. LPR devices can provide accurate and reliable target resolution to identify water levels in rivers and dams or critical levels of materials such as fuel, sewer-treated waste, and high risk substances, reducing overflow and spillage and minimizing exposure of maintenance personnel in the case of high risk materials. The Commission is proposing a set of rules that would be applicable to LPR devices (including TLPR devices) that would allow the expanded development of a variety of radar level-measuring products that will benefit the public and industry and improve the accuracy and reliability of these measuring tools beyond that which is permitted under our current part 15 rules. To the extent practicable, these proposals would also harmonize our technical rules for LPR devices with similar European standards in an effort to improve the competitiveness of U.S. manufacturers in the global economy. The Commission believes that, with appropriate rules, LPR devices can operate on an unlicensed basis in the proposed frequency bands without causing harmful interference to authorized services.

3. On January 14, 2010, the Commission adopted theNotice and Orderin this proceeding in response to: (1) a Petition for Rulemaking from Siemens Milltronics Process Instruments Inc. (Siemens) requesting that the Commission amend its rules to allow TLPR devices to operate in the “restricted” 77-81 GHz frequency band inside steel or concrete tank enclosures; (2) a concurrent request for waiver, also by Siemens, of § 15.205(a) to allow TLPR operation in the 78-79 GHz frequency band, subject to certain conditions; and (3) a similar request for waiver by Ohmart/VEGA Corporation (Ohmart/VEGA) to allow TLPR operation in the 77-81 GHz band. TheNotice and Orderproposed to modify part 15 of the rules to allow the 77-81 GHz frequency band to be used on an unlicensed basis for the operation of LPR equipment installed inside closed storage tanks made of metal, concrete, or other material with similar attenuating characteristics and also sought comment on whether to allow TLPR operation on an unlicensed basis in the 75-85 GHz band. TheNotice and Orderalso sought comment on whether the Commission should allow installation of TLPR devices in tanks made of materials with a lower attenuation coefficient than steel/concrete, including open-air installations, and requested input on additional measures to ensure that TLPR devices installed in such enclosures comply with the radiated emissions limit outside the tank. No comments were received in opposition to the specific proposals set forth in theNotice and Order,but no comments were received regarding open-air installations or other containers. TheOrdergranted waivers of the restriction on spurious emissions in the 77-81 GHz band set forth in § 15.205(a) to Siemens, Ohmart/VEGA, and any other responsible party that meets the specified waiver conditions, to permit TLPR devices to be installed inside tanks with high attenuation characteristics,e.g.,steel or concrete, pending the conclusion of the concurrently initiated rulemaking.

4. To date, the Commission has authorized LPR devices primarily for use in tanks upon demonstration of compliance with § 15.209 of the rules, which specifies an average EIRP limit of −41.3 dBm for operations above 960 MHz. In addition, § 15.35(b) of the rules sets a peak limit at 20 dB above the average limit,e.g.,a peak EIRP limit of −21.3 dBm. For pulsed signals, it may be necessary to take into account the limitations of the measurement instrumentation to determine the total peak power level, through the use of a pulse desensitization correction factor (PDCF), which is an adjustment factor that must be added to the indicated value of a pulsed emission on a spectrum analyzer when the emission bandwidth of the pulse exceeds the resolution bandwidth of the analyzer. Therefore, pulsed LPR devices often must reduce their peak power output to comply with the peak emission limit in § 15.209 and thus may sacrifice the necessary precision and accuracy required in many applications. LPR devices using other modulation techniques,e.g.,FMCW, also need wider bandwidth in certain frequencyranges to achieve the necessary measurement precision.

5. On January 26, 2010, the Commission placed on public notice a request for waiver of § 15.252(a) of the Commission's rules filed by Ohmart/VEGA to permit certification of LPR devices installed at fixed locations at outdoor sites as well as inside storage tanks in the 24.6-27 GHz frequency band. On January 3, 2011, the Commission also received a request for waiver of the frequency band restrictions of § 15.250 from Sutron Corporation to operate its water level probing radar in the 5.460-7.250 GHz frequency band with fixed outdoor infrastructure. Because these waiver requests raise issues that are, in part, similar to those raised in this FNPRM, we are holding these two requests in abeyance pending final action in this rulemaking proceeding.

6. In the FNPRM, the Commission proposes a set of rules that would be applicable to LPR devices used in any RF level-measuring application, whether in an open-air environment or inside an enclosure, to address the needs for a comprehensive and consistent approach to LPR devices. These proposals are intended to allow for the introduction of more diverse applications of LPRs in several frequency bands and improve the accuracy and reliability of these level-measuring tools beyond what is permitted under our current part 15 rules. The Commission also believes that the proposed rules will help to simplify equipment development and certification of LPR devices as well as provide a simplified method for measuring the radiated emissions from these devices.

7. The Commission has previously authorized LPR devices primarily for use in tanks upon demonstration of compliance with § 15.209 of the rules, which specifies an average EIRP limit of −41.3 dBm for operations above 960 MHz. In addition, these devices have also been required to demonstrate that they comply with § 15.35(b) of the rules, which sets a peak limit at 20 dB above the average limit,e.g.,a peak EIRP limit of −21.3 dBm. Pulsed LPR devices often must reduce their peak power output in order to comply with this peak emission limit and thus may sacrifice the necessary precision and accuracy required by many applications. LPR devices using other modulation techniques,e.g.,FMCW, also need wider bandwidth in certain frequency ranges to achieve the necessary measurement precision. LPR devices need higher power and wider bandwidth than permitted under § 15.209 of the rules to fully achieve the potential of RF level-measuring technology. In addition, the part 15 rules for similar wide-band devices such as §§ 15.250 or 15.252 contain frequency and operational restrictions which preclude the certification of LPR devices absent a waiver.

8. In expanding the scope of this rulemaking proceeding, the Commission is responding to an industry-wide need to employ wider bandwidth and higher power to implement more diverse applications in RF level-measuring while maintaining or improving accuracy and reliability. Specifically, it proposes to amend part 15 to provide a set of new rules to govern specifically the operation of LPR devices installed both in open-air environments and inside storage tanks (TLPR applications) in the following frequency bands: 5.925-7.250 GHz, 24.05-29.00 GHz, and 75-85 GHz. To permit LPR operation in the 75-85 GHz band, the Commission also proposes to modify existing § 15.205 of the rules to remove the prohibition on intentional emissions in this band. The Commission further proposes to treat LPR and TLPR devices the same with respect to emission limits and frequency bands of operation without any additional installation limitations. That is, a level measuring radar that complies with our proposed rules would be able to be used in any application, whether outdoors in the open or inside any type of enclosure. Accordingly, the proposals for emission limits in this FNPRM would supersede the emission limit proposals for TLPR devices in theNotice and Order.

9. The Commission is proposing emission limits for the main-beam emissions which are based on the ETSI LPR Technical Standard and take into account the fact that there may be no additional attenuation provided by a tank enclosure. The proposed limits would allow the main-beam emissions from LPRs to be higher in power than is allowed under the general emission limits in § 15.209. However, the levels of reflected emissions are not expected to exceed those general emission limits, and therefore no increased potential for interference is expected. The Commission also proposes to require that all spurious/unwanted emission limits from LPRs not exceed the general emission limits in § 15.209 when measured in the main beam of a device's transmit antenna; the measurement procedure would also utilize elevation and azimuth measurement scans to determine the location at which these unwanted emissions are maximized. To further protect authorized services operating in the same and adjacent frequency bands, the Commission proposes to: (1) Require the LPR antenna to be dedicated or integrated as part of the transmitter and professionally installed in a downward position; (2) limit installations of LPR devices to fixed locations; and (3) prohibit hand-held applications of LPR and the marketing of LPR devices to residential consumers.

10. The Commission based these proposals on the various waiver and informal rule interpretation requests it has received, and the emission limits adopted in Europe for LPR devices. Although our proposals would generally harmonize our rules with the European

LPR regulations with respect to the limits for fundamental emissions, they also would address the specific spectrum needs and restrictions in the U.S.

11.Frequency Bands of Operation.The Commission proposes to allow LPR operation under the new technical rules in the following frequency bands: 5.925-7.250 GHz, 24.05-29.00 GHz, and 75-85 GHz. In theNotice and Order,it proposed rules for TLPR devices in the 77-81 GHz band; in this FNPRM the Commission proposes to expand the frequency bands for LPR operation under the new rules for both in-tank and in open-air environments to include the 75-85 GHz band. It seeks comment on our proposals for LPR operation in each of the frequency bands discussed.

12. The Commission believes, that allowing LPR devices to operate under the technical rules it proposed herein will not increase the likelihood of harmful interference to incumbent authorized radiofrequency operations. LPR devices are typically installed at fixed industrial sites, such as quarries, paper mills, and ore refineries, or at facilities adjacent to bodies of water, such as dams, storm water lift stations, and sewage treatment plants, all of which are generally well away from residences. The Commission also proposed requiring LPR devices to utilize narrow beamwidth transmit antennas focused in a downward orientation. This will serve to minimize the likelihood of interference to any incumbent spectrum operations within proximity of a fixed LPR system. Finally, the emission limits proposed herein for LPR devices will ensure that incumbent operations are afforded similar protection as currently provided by the existing emission limits in § 15.209 of the rules.

13. Currently, unlicensed wide-band transmitter operation within the 5.925-7.250 GHz band is permitted under § 15.250 of our rules. In this band, licensed uses include non-Federal fixed,fixed satellite, and mobile services from 5.925 MHz to 7.125 MHz; and Federal fixed and space research services (deep space & Earth-to-space) from 7.125 MHz to 7.250 MHz. Part 15 transmitters operating in this band are prohibited from being used in toys or operating on board an aircraft or satellite. They cannot utilize a fixed outdoor infrastructure, including outdoor-mounted transmit antennas, to establish a wide area communications network. The Commission believes that its proposal to adopt rules to permit LPR operation in the 5.925-7.250 GHz band, including permitting limited fixed outdoor installations, is consistent with the intent underlying the usage restrictions in § 15.250. In this regard, LPRs will be single,i.e.,relatively isolated, transmitters whose individual operations outdoors will not result in a dense deployment of transmitters.

14. Unlicensed wide-band operation in the 23.12-29.0 GHz band is permitted under § 15.252 of our rules. This band is shared between Federal and non-Federal services. Authorized licensed operations include radiolocation, EESS (active), amateur, fixed, inter-satellite, radionavigation, radiolocation satellite (Earth-to-space), fixed satellite (Earth-to-space), mobile, standard frequency and time signal satellite (Earth-to-space), space research (space-to-Earth), and EESS (space-to-Earth) services. Currently, unlicensed transmitters operating in this band must be mounted on vehicles and cannot be used in aviation applications. To provide expanded flexibility for optimizing LPR applications and to enhance global marketing opportunities by more closely harmonizing with ETSI in this frequency range, the Commission proposes to permit LPR operation in the 24.05-29.00 GHz band. The proposed frequency band is wider than that which ETSI has adopted; however, the Commission believes that the risk of interference to incumbent authorized services from LPR devices will be no greater than it is from existing part 15 radars currently operating in this band because LPR devices operate in a fixed downward-looking position.

15. Apart from a few exceptions, all spectrum above 38.6 GHz, including the 75-85 GHz band, is designated by footnote as a “restricted band” in § 15.205 of the rules. Consequently, unless expressly permitted by rule or waiver, unlicensed devices are not allowed to intentionally radiate energy into a restricted band in order to protect sensitive radio services from harmful interference. The Commission has permitted unlicensed operation within specific frequency bands above 38.6 GHz,e.g.,46.7-46.9 GHz, 57-64 GHz, 76-77 GHz, and 92-95 GHz.

16. The 75-85 GHz band is shared between Federal and non-Federal services. Authorized operations in this band currently include radio astronomy, fixed/mobile/fixed satellite, mobile satellite, broadcast and broadcast satellite, radiolocation, space research (space-to-Earth), amateur and amateur satellite services. In addition, unlicensed vehicular radars are currently permitted to operate in the 76-77 GHz band. The services in this band typically employ highly directional antennas to overcome the relatively higher propagation loss that occurs at these frequencies. In theNotice and Order,the Commission proposed to allow TLPR operation in the 77-81 GHz band and also sought comment on whether it should permit TLPR devices to operate in the broader 75-85 GHz band. No objections were received from incumbent service operators with respect to TLPR operation in the 75-85 GHz band in response to theNotice and Order. The Commission believes that an extension of the frequency range to allow LPR operation in the 75-85 GHz band will not adversely affect incumbent authorized users, because this band is currently sparsely used and the propagation losses are significant at these frequencies, making harmful interference unlikely beyond a short distance from the LPR device. The Commission seeks comment on this proposal.

17.Radiated Emission Limits.The Commission proposes to adopt radiated emission limits for LPR devices operating in each of the proposed frequency bands as set forth in the table below. These limits are consistent with those adopted by ETSI. ETSI derived its emission limits for main-beam emissions by mathematically correlating the reflected emissions from an LPR with the existing part 15 average emission limit for devices operating above 960 MHz. The proposed emission limits therefore would maintain the existing level of interference protection to incumbent radio services. The Commission also believes that harmonization of our limits with the ETSI limits is desirable because it could serve to expand global marketing opportunities for U.S. manufacturers.

5.925-7.250−33+7−5524.05-29.00−14+26−41.375-85−3+34−41.3Notes:1. Minimum bandwidth at the −10 dB points is 50 megahertz.2. All emission limits defined herein are based on boresight measurements (i.e.,measurements performed within the main beam of an LPR antenna).3. Equivalent reflected emissions include antenna back-lobe and side-lobe emissions and worst-case reflections from material being measured.

18. ETSI/ECC based these limits on the results of mathematical modeling which was supported by measurement data. ETSI/ECC's modeling effort shows that if the LPR complies with the main-beam (boresight) emission limits specified in the second and third columns of the table above, any reflected emissions, including antenna back-lobe or side-lobe emissions and worst-case reflections from the target material, will also comply with the existing average emission limit specified in § 15.209 for devices operating above 960 MHz, shown in the table's fourth column. The main-beam emission limits vary with frequency band because the mathematical models accounted for the frequency-dependent propagation loss characteristics associated with each band. The Commission seeks comment on these proposed emission limits.

19. The Commission believes that the proposed LPR emission limits as measured in the main beam of the LPR antenna will adequately protect against harmful interference to incumbentauthorized services in any of the proposed frequency bands, based on several factors. First, LPR devices will be required to utilize downward-focused narrow-beam transmit antennas, which are also needed to optimize level-measuring performance. Therefore, the only LPR emissions likely to be incident on an incumbent receiver within proximity will be reflected from the target material and thus significantly attenuated. Second, the proposed LPR emission limits are consistent with the results expected from application of the existing limits in radiatedin situmeasurements and therefore will maintain the existing level of protection afforded to incumbent authorized services. Third, as the operating frequency increases, the propagation path loss also increases as a result of the increased attenuating effects on radio waves from intervening objects and atmospheric conditions. Finally, the Commission is proposing certain operational conditions that would further reduce the likelihood of harmful interference to authorized services. Accordingly, it concludes that LPR devices will be able to share spectrum with incumbent authorized services in the proposed bands at the proposed emission limits. The Commission seeks comment on this tentative conclusion.

20. In theNotice and Order,for TLPR devices operating in the 77-81 GHz band in tanks with very high RF attenuation characteristics,e.g.,steel or concrete, the Commission proposed an emission limit of +43 dBm on the transmitter's peak EIRP and +23 dBm on the transmitter's average EIRP levels for fundamental emissions when measured in a laboratory setting,i.e.,not installed in a tank. It also proposed to limit the radiated emissions from the TLPR device, when installed in representative tanks of each material type for testingin situ,to the general radiated emission limits for intentional radiators in § 15.209(a) of its rules when measured outside of the TLPR tank enclosure in any direction. The Commission stated that emissions outside of the tank will likely be minimal when considering the tank enclosure's attenuation coefficient in addition to the absorption characteristics of the target material (liquid or solid), and thus, any reflected signal will be mostly contained within the tank. The Commission also noted thatin situtesting would require performance of compliance tests on a tank of each material type intended for use with the LPR at three representative installation sites (e.g.,a metallic tank at three representative installation sites, a concrete tank at three representative installation sites), which could prove quite burdensome to an applicant.

21. The Commission is now proposing to treat TLPR devices in the same manner as LPR devices with respect to both emission limits and frequency bands of operation. Thus, if an LPR complies with these proposed rules, it can be installed inside an enclosure or out in the open since the proposed emission limits do not assume any additional attenuation provided by a tank enclosure. Although the emission limits proposed herein are somewhat lower than the TLPR limits previously-proposed (e.g.,+34 dBm peak EIRP vs. +43 dBm peak EIRP, respectively), the Commission notes that the proposed limits do not assume any tank enclosure attenuation. It believes that this will alleviate the burdens involved in performingin situcompliance testing. These proposals also will permit TLPR devices to be used with a variety of tank materials, potentially increasing the useful applications of the technology. Accordingly, the Commission is proposing a definition for LPR devices that would encompass open-air and in-tank applications. The Commission seeks comment on these proposals.

22.Antenna Beamwidth.The Commission notes that the ECC recommendations are based on modeling results that assume the LPR antenna beamwidth is limited to less than 12 degrees for frequencies below 57 GHz and less than 8 degrees in the 75-85 GHz bands. It also notes that maintaining a narrow antenna beamwidth is also a performance criterion for optimizing LPR operations because a narrower beam reduces false echoes from objects other than the desired target material. The Commission proposes to adopt these antenna beamwidth requirements and seek comment on this proposal.

23.Antenna Side Lobe Gain.In assessing compatibility between LPR devices and systems operating in other radio services, the ETSI/ECC modeling effort assumed a maximum side lobe antenna gain of −10 dBi for off-axis angles from the main beam of greater than 60 degrees. In addition to the requirements for antenna beamwidth, the Commission seeks comment on the necessity of establishing limits on the gain of the antenna in the side lobe region and off-axis angle where the gain is to be defined.

24.Automatic Power Control.ECC also recommends the implementation of automatic power control (APC) with a dynamic range of 20 dB for LPRs. The Commission notes that as a consequence of our proposed emission limits, all reflected emissions from the LPR device will be kept at or below the § 15.209 general emission limits. Thus, as tentatively concluded, harmful interference to other spectrum users is not expected. Therefore, the Commission does not propose to adopt APC requirements for LPR devices. Any party advocating a requirement for APC should provide technical analyses as to why the emission limit in § 15.209 is not adequate.

25.Compliance Measurement.As stated, a primary reason for ECC adoption of a main-beam emission limit for LPR devices is to reduce the difficulties associated with measuring reflected emissions from an LPR devicein situ.The Commission also notes, in concurrence with ETSI/ECC, that the current compliance practice of measuring reflected radiated emissions at a 3-meter horizontal distance from the radiating source while varying the measurement antenna height from 1 meter to 4 meters often does not yield repeatable results when LPR emissions are measuredin situ.This is because the patterns of reflected emissions tend to vary and are therefore difficult to measure consistently, propagation losses in the higher frequency bands are significant, and it is not always practical to create a test bed that is representative of all of the substances that an LPR will measure, making it difficult to determine the worst-case reflectivity factor. In addition, the current measurement procedure does not consider any potential emissions that may radiate from the top of an LPR device. The limits proposed herein will account for such emissions that could be missed entirely when applying the existingin situcompliance measurement procedures. With a main-beam emission limit, emissions are to be evaluated with the measurement antenna pointed directly at the LPR antenna, and as long the LPR complies with this limit, its reflected emissions in any direction will generally not exceed the existing average emission limit in § 15.209, thereby maintaining the same level of interference protection to incumbent authorized users. The Commission tentatively concludes that the main-beam emission limit will facilitate representative, reliable, and repeatable emission measurements of the emissions from LPR devices. The Commission seeks comment on this tentative conclusion.

26. Based on our experience to date with compliance measurements of and the proposals herein for main-beam emission limits for LPR devices, the Commission seek comment on the following compliance measurement procedures. The Commission's Office ofEngineering and Technology may publish specific information on how to conduct compliance testing following these procedures,e.g.,by publication in a guidance document or as specified in the rules.

• Radiated measurements of the fundamental emission bandwidth and power shall be made with maximum main beam coupling between the LPR and test antennas (boresight).

• Measurements of the unwanted emissions radiating from an LPR shall be made utilizing elevation and azimuth scans to determine the location at which the emissions are maximized.

• All emissions at and below 960 MHz shall be measured with a CISPR quasi-peak detector.

• The fundamental emission bandwidth measurement shall be made using a peak detector with a resolution bandwidth of 1 MHz and a video bandwidth of at least 3 MHz.

• The provisions in § 15.35(b) and (c) that limit the peak power to 20 dB above the average limit and require emissions to be averaged over a 100 millisecond period do not apply to devices operating under this section.

• Compliance measurements of frequency-agile LPR devices shall be performed with any related frequency sweep, step, or hop function activated.

27.Operational and Marketing Restrictions.The Commission proposes to adopt operational restrictions to require the antenna of an LPR device to be dedicated or integrated as part of the transmitter and professionally installed in a downward position; to limit installations of LPR devices to fixed locations; to prohibit hand-held applications of LPR devices; and to prohibit the marketing of LPR devices to residential consumers. The Commission proposes these restrictions to protect incumbent authorized services operating in the same and adjacent frequency bands from harmful interference. It seeks comment on these proposals.

28.Equipment Certification.In theNotice and Order,the Commission proposed to require that TLPR devices designed to operate in the 77-81 GHz band be approved under the Commission's certification procedures and that certification be performed by the Commission's Laboratory rather than by Telecommunications Certification Bodies (TCB). The Commission noted that because a standard test procedure for LPR devices had not yet been devised for use at these frequencies, this requirement would give the Commission time to develop appropriate measurement guidelines for devices intended for operation in this frequency band. It observes, however, that the new proposals made herein will facilitate the direct measurement of emissions within the main beam of the LPR antenna and are consistent with compliance measurement methodologies currently used with other types of unlicensed transmitters. The Commission therefore proposes to permit TCBs to certify LPR devices operating under these proposed rules. The Commission seeks further comment on this proposal.

29. The Commission is aware that some approvals of TLPRs have already been granted under § 15.209 of our rules. These devices may continue to operate under § 15.209 if their worst-case radiated emissions continue to comply with the limits in these rules. The Commission recognizes that a certified TLPR device could be approved to operate under other conditions,e.g.,outdoor installations in open-air environments, in an enclosure with low RF attenuation characteristics, or with higher power. To allow previously-certified devices to take advantage of the changes proposed in this FNPRM, the Commission proposes to allow the responsible party to file for a permissive change request in accordance with the existing rules and practices, provided that: (1) The LPR device operates only within the frequency bands authorized by rules proposed herein; (2) measurement data taken in accordance with the measurement procedure proposed above is provided to demonstrate compliance with the new emission limits specified in these proposed rules; and (3) operational changes to the device are being implemented by software upgrade without any hardware change. The Commission seeks comment on this proposal.

30.Cost Benefit Analysis.The Commission believes that the benefits of the proposed regulations for manufacturers and users outweigh any potential costs. LPR devices need higher power and wider bandwidth than that which is permitted under the existing part 15 rules to fully achieve the potential of this measuring technology. The Commission's proposed rules would provide a necessary remedy for these devices to operate at the power levels and in the appropriate frequency bands required to deliver the needed accuracy for diverse applications, thereby promoting the expanded development and use of this technology to the benefit of businesses, consumers, and the economy. The proposed higher power levels in the proposed frequency bands would further the development of better and improved level-measuring tools, but these changes would not increase the potential for interference to authorized users beyond what is permitted under the current rules. In addition, the proposed rules will help to simplify equipment development and certification of LPR devices, as well as provide a simplified method for measuring the radiated emissions from these devices. The Commission seeks comment on this analysis and any additional benefits that may result from these proposed rules. Parties that oppose these proposed rules should cite specific harms that they believe would result from changing the rules.

Initial Regulatory Flexibility Analysis

31. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),1the Commission has prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this Further Notice of Proposed Rule Making (FNPRM). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments provided on the first page of this FNPRM. The Commission will send a copy of this FNPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA).2

1See5 U.S.C. 603. The RFA,see5 U.S.C. 601-612, has been amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 847 (1996).

2See5 U.S.C. 603(a).

A. Need for, and Objectives of, the Proposed Rules

32. This rule making proposal is initiated to obtain comments regarding proposed changes to the regulations for radio frequency devices that do not require a license to operate. The Commission proposed to expand the scope of the above proceeding to adopt technical rules for operation of specific types of low-power transmitters called level probing radar (LPR) devices, including tank level probing radars (TLPR), on an unlicensed basis under the provisions of part 15 of the Commission's rules in the following frequency bands: 5.925-7.250 GHz, 24.05-29.00 GHz and 75-85 GHz. The Commission proposed to amend its part 15 rules to revise the original proposed § 15.256 in theNotice of Proposed Rule Making and Order(Notice and Order) to permit the operation of LPR devices installed both outdoors in the open and inside storage tanks (TLPR) in the abovefrequency bands. The Commission propose to treat LPR and TLPR devices the same with respect to emission limits and frequency bands of operation without any additional installation limitation. That is, a level-measuring radar that complies with our proposed rules will be able to be used in any application, whether outdoors in the open or inside any type of enclosure,e.g.,steel or plastic. These proposals will also extend the operation of TLPR devices from the originally proposed 77-81 GHz band to the additional proposed frequency bands, at the new proposed main-beam emission limits. The Commission proposes emission limits for fundamental emissions depending on the LPR frequency bands of operation, as measured in the antenna main beam, based on the LPR Technical Standards adopted in Europe, to promote savings for manufacturers that operate in the global economy. The Commission proposes to require that all spurious/unwanted emission limits not exceed the general emission limits in § 15.209 when measured in the main beam of the LPR antenna, as well as utilizing elevation and azimuth scans to determine the location at which the emissions are maximized. To further protect authorized services operating in the same and adjacent frequency bands, we also propose to adopt operational restrictions to require the LPR antenna to be dedicated or integrated as part of the transmitter and professionally installed in a downward position; to limit installations of LPR devices to fixed locations; and to prohibit hand-held applications of LPR and the marketing of LPR devices to consumers. The Commission believes that its proposals herein would enable LPR devices that will provide better accuracy and reliability in target resolution to identify critical levels of materials such as fuel, water and sewer treated waste, and high-risk substances. The proposed amendments to our rules will permit these devices to operate effectively and reliably, reducing storage tank overfill and spilling and minimizing exposure of maintenance personnel in the case of high-risk materials, all without increasing the risk of interference to authorized services.

C. Description and Estimate of the Number of Small Entities to Which the Proposed Rules Will Apply

34. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted.3The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.”4In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.5A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.6

35 U.S.C. 603(b)(3).

45 U.S.C. 601(6).

55 U.S.C. 601(3) (incorporating by reference the definition of “small business concern” in 15 U.S.C. 632). Pursuant to the RFA, the statutory definition of a small business applies “unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in theFederal Register.” 5 U.S.C. 601(3).

6Small Business Act, 15 U.S.C. 632 (1996).

35.Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing.The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.”7The SBA has developed a small business size standard for Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing, which is all such firms having 750 or fewer employees.8According to Census Bureau data for 2002, there were a total of 1,041 establishments in this category that operated for the entire year.9Of this total, 1,010 had fewer than 500 employees, and an additional 13 had between 500 and 999 employees.10Thus, under this size standard, the majority of firms can be considered small.

9U.S. Census Bureau, American FactFinder, 2002 Economic Census, Industry Series, Industry Statistics by Employment Size, NAICS code 334220 (released May 26, 2005);http://factfinder.census.gov.The number of “establishments” is a less helpful indicator of small business prevalence in this context than would be the number of “firms” or “companies,” because the latter takes into account the concept of common ownership or control. Any single physical location for an entity is an establishment, even though that location may be owned by a different establishment. Thus, the numbers given may reflect inflated numbers of businesses in this category, including the numbers of small businesses. In this category, the Census Bureau breaks-out data for firms or companies only to give the total number of such entities for 2002, which was 929.

10Id.An additional 18 establishments had 1,000 or more employees.

36.Wireless Service Providers.The SBA has developed a small business size standard for wireless firms within the two broad economic census categories of “Paging”11and “Cellular and Other Wireless Telecommunications.”12Under both categories, the SBA deems a wireless business to be small if it has 1,500 or fewer employees. For the census category of Paging, Census Bureau data for 2002 show that there were 807 firms in this category that operated for the entire year.13Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more.14Thus, under this category and associated small business size standard, the majority of firms can be considered small. For the census category of Cellular and Other Wireless Telecommunications, Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year.15Of this total, 1,378 firms had 999 or fewer employees, and 19 firms had 1,000 employees or more.16Thus, under this second category and size standard, the majority of firms can, again, be considered small.

16Id.The census data do not provide a more precise estimate of the number of firms that have 1,500 or fewer employees; the largest category provided is for firms with “1,000 employees or more.”

37. The Commission has proposed to reduce burdens wherever possible. Our proposals for new technical rules regarding LPR operation in the 5.925-7.250 GHz, 24.05-29.00 GHz, and 75-85 GHz would reduce burdens on small entities. LPR operation in these bands will increase the utilization of this spectrum by allowing a radio-frequency type of level-measuring technology to access the spectrum that is currently not used under the current technical rules for these types of industrial applications, resulting in more efficient use of these bands. Where possible we have made an effort to harmonize with international technical standards in Europe to promote cost savings for small manufacturers competing in the global economy. The Commission will continue to examine further alternatives with the objectives of eliminating unnecessary regulations and minimizing significant economic impact on small entities. The Commission seeks comment on significant alternatives commenters believe it should adopt.

38. The Commission does expect that the rules proposed in this Further Notice of Proposed Rule Making will have a significant negative economic impact on small businesses.

D. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements

39. Part 15 transmitters already are required to be authorized under the Commission's certification procedure as a prerequisite to marketing and importation. The reporting and recordkeeping requirements associated with these equipment authorizations would not be changed by the proposals contained in this FNPRM. The changes to the regulations would permit operation of unlicensed radar devices used in specific industrial applications at frequencies already used by other part 15 devices and in a higher frequency band (75-85 GHz).

E. Federal Rules That May Duplicate, Overlap or Conflict With the Proposed Rules

42.Notice is hereby givenof the proposed regulatory changes described in this Further Notice of Proposed Rulemaking, and that comment is sought on these proposals.

43. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center,shall senda copy of this Further Notice of Proposed Rule Making, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

Federal Communications Commission.

Marlene H. Dortch,Secretary.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 15 to read as follows:

PART 15—RADIO FREQUENCY DEVICES

1. The authority citation for part 15 continues to read as follows:

Authority:

47 U.S.C. 154, 202, 303, 304, 307 and 544A.

2. Section 15.3 is amended by adding paragraph (hh) to read as follows:

§ 15.3Definitions.

(hh)Level Probing Radar (LPR):A short-range radar transmitter used in a wide range of applications to measure the amount of various substances, mostly liquids or granulates. LPR equipment may operate in open-air environments or inside an enclosure containing the substance being measured.

3. Section 15.31 is amended by revising paragraph (c) to read as follows:

§ 15.31Measurement standards.

(c) Except as otherwise indicated in § 15.256, for swept frequency equipment, measurements shall be made with the frequency sweep stopped at those frequencies chosen for the measurements to be reported.

4. Section 15.35 is amended by revising paragraph (b) to read as follows:

§ 15.35Measurement detector functions and bandwidths.

(b) Unless otherwise specified, on any frequency or frequencies above 1000 MHz, the radiated emission limits are based on the use of measurement instrumentation employing an average detector function. Unless otherwise specified, measurements above 1000 MHz shall be performed using a minimum resolution bandwidth of 1 MHz. When average radiated emission measurements are specified in this part, including average emission measurements below 1000 MHz, there also is a limit on the peak level of the radio frequency emissions. Unless otherwise specified,see, e.g.,§§ 15.250, 15.252, 15.255, 15.256 and 15.509-15.519 of this part, the limit on peak radio frequency emissions is 20 dB above the maximum permitted average emission limit applicable to the equipment under test. This peak limit applies to the total peak emission level radiated by the device,e.g.,the total peak power level. Note that the use of a pulse desensitization correction factor may be needed to determine the total peak emission level. The instruction manual or application note for the measurement instrument should be consulted for determining pulse desensitization factors, as necessary.

5. Section 15.205 is amended by revising paragraph (d)(4) to read as follows:

§ 15.205Restricted bands of operation.

(d) * * *

(4) Any equipment operated under the provisions of §§ 15.253, 15.255, 15.256 in the frequency band 75-85 GHz, or § 15.257 of this part.

(a) Operation under this section is limited to level probing radar (LPR) devices.

(b) LPR devices operating under the provisions of this section shall utilize a dedicated or integrated transmit antenna, and the system shall be professionally installed and maintained to ensure a downward orientation of the transmit antenna.

(c) LPR devices operating under the provisions of this section shall be installed only at fixed locations.

(d) Hand-held applications and marketing to residential consumers are prohibited.

(e) The fundamental bandwidth of an LPR emission is defined as the width of the signal between two points, one below and one above the center frequency, outside of which all emissions are attenuated by at least 10 dB relative to the maximum transmitter output power when measured in an equivalent resolution bandwidth.

(1) The minimum fundamental emission bandwidth shall be 50 MHz for LPR operation under the provisions of this section.

(2) LPR devices operating under this section must confine their fundamental emission bandwidth within the 5.925-7.250 GHz, 24.05-29.00 GHz, and 75-85 GHz bands under all conditions of operation.

(f) Fundamental Emissions Limits

(1) All emission limits provided in this section are expressed in terms of Equivalent Isotropic Radiated Power (EIRP).

(2) The EIRP level is to be determined from the maximum measured power within a specified bandwidth.

(i) The EIRP in 1 MHz is computed from the maximum power level measured within any 1-MHz bandwidth using a power averaging detector;

(ii) The EIRP in 50 MHz is computed from the maximum power level measured with a peak detector in a 50-MHz bandwidth centered on the frequency at which the maximum average power level is realized.

(3) The EIRP limits for LPR operations in the bands authorized by this rule section are provided in the following table:

Frequency band of operation (GHz)EIRP limit in 1 MHz

(dBm)

EIRP limit in 50 MHz

(dBm)

5.925-7.250−33724.05-29.00−142675-85−334

(g) Unwanted Emissions Limits

(1) All emission limits provided in this section are expressed in terms of Equivalent Isotropic Radiated Power (EIRP) and are computed based on the maximum average power level measured within any 1-MHz bandwidth.

(1) LPR devices operating under the provisions of this section within the 5.925-7.250 GHz and 24.05-29.00 GHz bands must use an antenna with a maximum half-power beamwidth of 12 degrees.

(2) LPR devices operating under the provisions of this section within the 75-85 GHz band must use an antenna with a maximum half-power beamwidth of 8 degrees.

(i) Antenna Side Lobe Gain

(1) LPR devices operating under the provisions of this section must limit the side lobe antenna gain to −10 dBi for off-axis angles from the main beam of greater than 60 degrees.

(j) Measurement Procedures

(1) Radiated measurements of the fundamental emission bandwidth and power shall be made with maximum main beam coupling between the LPR and test antennas (boresight).

(2) Measurements of the unwanted emissions radiating from an LPR shall be made utilizing elevation and azimuth scans to determine the location at which the emissions are maximized.

(3) All emissions at and below 960 MHz are based on measurements employing a CISPR quasi-peak detector.

(4) The fundamental emission bandwidth measurement shall be made using a peak detector with a resolution bandwidth of 1 MHz and a video bandwidth of at least 3 MHz.

(5) The provisions in § 15.35(b) and (c) of this part that require emissions to be averaged over a 100 millisecond period and that limit the peak power to 20 dB above the average limit do not apply to devices operating under this section.

(6) Compliance measurements of frequency-agile LPR devices shall be performed with any related frequency sweep, step, or hop function activated.

(7) Compliance measurements shall be made in accordance with the specific procedures published or otherwise authorized by the Commission.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Proposed rule; request for comments.

SUMMARY:

NMFS proposes management measures for the 2012 summer flounder, scup, and black sea bass recreational fisheries. The implementing regulations for these fisheries require NMFS to publish recreational measures for the fishing year and to provide an opportunity for public comment. The intent of these measures is to prevent overfishing of the summer flounder, scup, and black sea bass resources.

DATES:

Comments must be received by 5 p.m. local time, on May 15, 2012.

ADDRESSES:

You may submit comments, identified by NOAA-NMFS-2012-0081, by any one of the following methods:

•Electronic Submissions:Submit all electronic public comments via the Federal e-Rulemaking portal:http://www.regulations.gov. To submit comments via the e-Rulemaking Portal, first click the “Submit a Comment” icon, then enter NOAA-NMFS-2012-0081 in the keyword search. Locate the document you wish to comment on from the resulting list and click on the “Submit a Comment” icon on the right of that line.

Instructions:Comments must be submitted by one of the above methods to ensure that the comments are received, documented, and considered by NMFS. Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered. All comments received are part of the public record and will generally be posted tohttp://www.regulations.govwithout change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

NMFS will accept anonymous comments (enter N/A in the required fields, if you wish to remain anonymous). You may submit attachments to electronic comments in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.

The summer flounder, scup, and black sea bass fisheries are managed cooperatively under the provisions of the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) developed by the Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission), in consultation with the New England and South Atlantic Fishery Management Councils. The management units specified in the FMP include summer flounder (Paralichthys dentatus) in U.S. waters of the Atlantic Ocean from the southern border of North Carolina (NC) northward to the U.S./Canada border, and scup (Stenotomus chrysops) and black sea bass (Centropristis striata) in U.S. waters of the Atlantic Ocean from 35 E. 13.3′ N. lat. (the latitude of Cape Hatteras Lighthouse, Buxton, NC) northward to the U.S./Canada border.

The Council prepared the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801et seq.Regulations implementing the FMP appear at 50 CFR part 648, subparts A (general provisions), G (summer flounder), H (scup), and I (black sea bass). General regulations governing fisheries of the Northeastern U.S. also appear at 50 CFR part 648. States manage these three species within 3 nautical miles (4.83 km) of their coasts, under the Commission's plan for summer flounder, scup, and black sea bass. The applicable species-specific Federal regulations govern vessels and individual fishermen fishing in Federal waters of the exclusive economic zone (EEZ), as well as vessels possessing a summer flounder, scup, or black sea bass Federal charter/party vessel permit, regardless of where they fish.

Recreational Management Measures Background

The Council process for devising recreational management measures to recommend to NMFS for rulemaking is generically described in the following section. All meetings are open to the public and the materials utilized during such meetings, as well as any documents created to summarize the meeting results, are public information and typically posted on the Council's Web site (www.mafmc.org) or are available from the Council by request. Extensive background on the 2012 recreational management measures recommendation process is therefore not repeated in this preamble.

The FMP established monitoring committees for the three fisheries, consisting of representatives from the Commission, the Council, state marine fishery agency representatives from MA to NC, and NMFS. The FMP's implementing regulations require the monitoring committees to review scientific and other relevant information annually and to recommend management measures necessary to constrain landings within the recreational harvest limits established for the summer flounder, scup, and black sea bass fisheries for the upcoming fishing year. The FMP limits the choices for the types of measures to minimum fish size, possession limit, and fishing season.

The Council's Demersal Species Committee and the Commission's Summer Flounder, Scup, and Black Sea Bass Management Board (Board) then consider the monitoring committees' recommendations and any public comment in making their recommendations to the Council and the Commission, respectively. The Council reviews the recommendations of the Demersal Species Committee, makes its own recommendations, and forwards them to NMFS for review. The Commission similarly adopts recommendations for the states. NMFS is required to review the Council's recommendations to ensure that they are consistent with the targets specified for each species in the FMP and all applicable laws and Executive Orders before ultimately implementing measures for Federal waters.

All minimum fish sizes discussed hereafter are total length measurements of the fish, i.e., the straight-line distance from the tip of the snout to the end of the tail while the fish is lying on its side. For black sea bass, total length measurement does not include the caudal fin tendril. All possession limits discussed below are per person.

Proposed 2012 Recreational Management Measures

NMFS is proposing the following measures that would apply in the Federal waters of the EEZ and to all federally permitted party/charter vessels with applicable summer flounder, scup, or black sea bass permits regardless of where they fish for the 2012 recreational summer flounder, scup, and black sea bass fisheries: For summer flounder, use of state-by-state conservation equivalency measures, which are the status quo measures; for scup, a 10.5-inch (26.67-cm) minimum fish size, a 20-fish per person possession limit, and an open season of January 1 through December 31; and, for black sea bass, a 12.5-inch (31.71-cm) minimum fish size, a 15-fish per person possession limit for a January 1 through February 29 open season, and a 25-fish per person possession limit for open seasons of May 19 through October 14 and November 1 through December 31. NMFS will consider retaining or reinstating status quo black sea bass measures, as needed, for Federal waters (i.e., a 12.5-in (31.75-cm) minimum fish size, a 25-fish per person possession limit, and fishing seasons from May 22-October 11 and November 1-December 31) if the Commission develops and implements a state-waters conservation equivalency system that, when paired with the Council's recommended measures, does not provide the necessary conservation to ensure the 2012 recreational harvest limit will not be exceeded. More detail on these proposed measures is provided in the following sections.

Summer Flounder Recreational Management Measures

The 2012 recreational harvest limit for summer flounder is 8.76 million lb (3,973 mt), as published in interim final rule (76 FR 82189, December 30, 2011). Final landings for 2011 are approximately 5.6 million lb (2,541.57 mt), well below the recreational harvest limit. The Council and Commission have recommended the use of conservation equivalency to manage the 2012 summer flounder recreational fishery.

NMFS implemented Framework Adjustment 2 to the FMP on July 29, 2001 (66 FR 36208), to permit the use of conservation equivalency to manage the recreational summer flounder fishery. Conservation equivalency allows each state to establish its own recreational management measures (possession limits, minimum fish size, and fishing seasons) to achieve its state harvest limit partitioned by the Commission from the coastwide recreational harvest limit, as long as the combined effect of all of the states' management measures achieves the same level of conservation as would Federal coastwide measures.

The Council and Board annually recommend that either state- or region-specific recreational measures be developed (conservation equivalency) or coastwide management measures be implemented by all states to ensure that the recreational harvest limit will not be exceeded. Even when the Council and Board recommend conservation equivalency, the Council must specify aset of coastwide measures that would apply if conservation equivalency is not approved for use in Federal waters.

When conservation equivalency is recommended, and following confirmation that the proposed state measures developed through the Commission's technical and policy review processes achieve conservation equivalency, NMFS may waive the permit condition found at § 648.4(b), which requires Federal permit holders to comply with the more restrictive management measures when state and Federal measures differ. In such a situation, federally permitted summer flounder charter/party permit holders and individuals fishing for summer flounder in the EEZ would then be subject to the recreational fishing measures implemented by the state in which they land summer flounder, rather than the coastwide measures.

In addition, the Council and the Board must recommend precautionary default measures when recommending conservation equivalency. The Commission would require adoption of the precautionary default measures by any state that either does not submit a summer flounder management proposal to the Commission's Summer Flounder Technical Committee, or that submits measures that would exceed the Commission-specified harvest limit for that state.

Much of the conservation equivalency measures development process happens at both the Commission and individual state level. The selection of appropriate data and analytic techniques for technical review of potential state conservation equivalent measures and the process by which the Commission evaluates and recommends proposed conservation equivalent measures is wholly a function of the Commission and its individual member states. Individuals seeking information regarding the process to develop specific state measure or the Commission process for technical evaluation of proposed measures should contact the marine fisheries agency in the state of interest, the Commission, or both.

Once states select their final 2012 summer flounder management measures through their respective development, analytical, and review processes and submit them to the Commission, the Commission will conduct further review and evaluation of the state-submitted proposals, ultimately notifying NMFS as to which individual state proposals have been approved or disapproved. NMFS has no overarching authority in the state or Commission management measure development, but is an equal participant along with all the member states in the measures review process. NMFS retains the final authority either to approve or to disapprove the use of conservation equivalency in place of the coastwide measures in Federal waters, and will publish its determination as a final rule in theFederal Registerto establish the 2012 recreational measures for these fisheries.

States that do not submit conservation equivalency proposals, or whose proposals are disapproved by the Commission, will be required by the Commission to adopt the precautionary default measures. In the case of states that are initially assigned precautionary default measures, but subsequently receive Commission approval of revised state measures, NMFS will publish a notice in theFederal Registerannouncing a waiver of the permit condition at § 648.4(b).

The 2012 precautionary default measures recommended by the Council and Board are for a 20.0-inch (50.80-cm) minimum fish size, a possession limit of two fish, and an open season of May 1 through September 30, 2012.

In this action, NMFS proposes to implement conservation equivalency with a precautionary default backstop, as previously outlined, for states that either fail to submit conservation equivalent measures or whose measures are not approved by the Commission. NMFS proposes the alternative of coastwide measures, as previously described, for use if conservation equivalency is not approved in the final rule. The coastwide measures would be waived if conservation equivalency is approved in the final rule.

Scup Recreational Management Measures

The 2012 scup recreational harvest limit is 8.45 million lb (3,833 mt), as published in interim final rule (December 30, 2011; 76 FR 82189). Estimated 2011 scup recreational landings are 3.48 million lb (1,580.39 mt). The Council and Commission's recommended measures for the 2012 scup recreational fishery are for a 10.5-in (26.67-cm) minimum fish size, a 20-fish per person possession limit, and an open season of January 1 through December 31. NMFS proposes to implement the recommended scup recreational management measures for 2012 in Federal waters.

NMFS acknowledges that the Commission has indicated its intent to continue managing the recreational scup fishery through a Commission-based conservation equivalency program that has no comparable measures in the Federal FMP. Thus, recreational management measures will differ between state and Federal waters in 2012. Historically, very little of the scup recreational harvest comes from the Federal waters of the EEZ. The scup recreational harvest from Federal waters for 2010 was approximately 4 percent of the total coastwide landings.

Black Sea Bass Recreational Management Measures

The 2012 black sea bass recreational harvest limit is 1.32 million lb (599 mt), as published in interim final rule (December 30, 2011; 76 FR 82189). The 2011 black sea bass recreational landings were 1.09 million lb (494 mt); however, at the time the Council and Commission were making recommendations for the 2012 recreational black sea bass fishery, the 2011 landings were estimated to be 0.99 million lb (449 mt).

The Council has recommended measures designed to allow for an increase in black sea bass recreational landings (from the estimated 0.99 million lb to the allowable 1.32 million lb). These measures for Federal waters are a 12.5-inch (31.75-cm) minimum fish size and a 15-fish per person possession limit for an open season of January 1 through February 28; and a 12.5-inch (31.75-cm) minimum fish size and a 25-fish per person possession limit for open seasons of May 19 through October 14 and November 1 through December 31.

The Commission is developing conservation equivalency measures for state waters based on the original 2011 landings, which would have allowed for an increase in landings and more flexibility. NMFS is proposing to implement the aforementioned Council-recommended measures for Federal waters while the Commission's process for determining state waters conservation equivalency proceeds. However, it may be necessary to maintain the status quo measures (12.5-inch (31.75-cm) minimum fish size, 25-fish per person possession limit, and an open season of May 22 through October 11 and November 1 through December 31), if the proposed Council recommended measures and the Commission's state waters conservation equivalency measures are likely to result in the recreational harvest limit being exceeded.

If the timing of this Commission process is complete, including the necessary correspondence to NMFS and the Council, before a final rule has been issued by NMFS for the 2011 recreational management measures, NMFS may implement the Council's recommended measures for Federalwaters. The decision to implement the Council's recommended measures for Federal waters will be contingent on the as of yet to be completed analyses and recommendation from the Commission, and any such decision would be relayed in the final rule published in theFederal Register. If the Commission conservation equivalency development process extends beyond the issuance of a recreational management measures final rule, NMFS may issue a second rule to implement the Council's recommended 2012 measures for Federal waters, pending the completion of the Commission process and concurrence by NMFS that the combination of state waters conservation equivalency and the Council's recommended measures will achieve the desired 2012 fishery performance. Should NMFS ultimately determine that the Commission's conservation equivalency measures for use in state waters for the 2012 fishery and the Council's recommended measures would likely result in the recreational harvest limit being exceeded, then Federal status quo measures would remain for the duration of the 2012 fishing year: A 12.5-inch (31.75-cm) minimum fish size, 25-fish possession limit, and May 22 through October 14 and November 1 through December 31 open seasons.

The proposed January 1 through February 29 open season has already passed, but would roll-over into fishing year 2013, if approved in the final rule. However, because the fishing year 2013 recreational harvest limit is unknown, it is not possible to determine the impact that this additional fishing opportunity would have on keeping the fishery within the 2013 recreational harvest limit. As such, if this additional season is approved and implemented in the final rule for the 2012 recreational harvest measures, NMFS may re-evaluate the open season during the 2013 specifications process.

Classification

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the Assistant Administrator has determined that this proposed rule is consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment. In order to ensure that any final rule can be published as soon as possible, NMFS is requesting that comments for this proposed rule be submitted within 15 days. This will allow interested parties adequate opportunity to comment while ensuring that NMFS can publish a final rule in a timely manner in an attempt to avoid a delay in the opening of the fishing season, should the proposed black sea bass fishing season be approved.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

The Council prepared an IRFA, as required by section 603 of the Regulatory Flexibility Act (RFA), which is included in the Supplemental EA and supplemented by information contained in the preamble to this proposed rule. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section of the preamble and in theSUMMARYof this proposed rule. A summary of the IRFA follows. A copy of this analysis is available from the Council (seeADDRESSES).

All of the entities (charter/party permitted fishing vessels) affected by this action are considered small entities under the Small Business Administration size standards for businesses in the recreational fishery with gross revenues of up to $7.0 million. Therefore, there are no disproportionate effects on small versus large entities. Information on costs in the fishery is not readily available and individual vessel profitability cannot be determined directly; therefore, expected changes in gross revenues were used as a proxy for profitability.

This action does not introduce any new reporting, recordkeeping, or other compliance requirements. This proposed rule does not duplicate, overlap, or conflict with other Federal rules.

Description and Estimate of Number of Small Entities to Which the Rule Would Apply

The proposed recreational management measures could affect any recreational angler who fishes for summer flounder, scup, or black sea bass in the EEZ or on a party/charter vessel issued a Federal permit for summer flounder, scup, and/or black sea bass. However, the only regulated entities affected by this action are party/charter vessels issued a Federal permit for summer flounder, scup, and/or black sea bass, and so the IRFA focuses upon the expected impacts on this segment of the affected public. These vessels are all considered small entities for the purposes of the RFA, i.e., businesses in the recreational fishery with gross revenues of up to $7.0 million. These small entities can be specifically identified in the Federal vessel permit database and would be impacted by the recreational measures, regardless of whether they fish in Federal or state waters. Although fishing opportunities by individual recreational anglers may be impacted by this action, they are not considered small entities under the RFA.

The Council estimated that the proposed measures could affect any of the 902 vessels possessing a Federal charter/party permit for summer flounder, scup, and/or black sea bass in 2010, the most recent year for which complete permit data are available. However, only 355 vessels reported active participation in the 2010 recreational summer flounder, scup, and/or black sea bass fisheries.

In the IRFA, the no-action alternative (i.e., maintenance of the regulations as codified) is: (1) For summer flounder, coastwide measures of a 18-inch (45.72-cm) minimum fish size, a 2-fish possession limit, and an open season from May 1 through September 30; (2) for scup, a 10.5-inch (26.67-cm) minimum fish size, a 10-fish possession limit, and an open season of June 6 through September 26; and (3) for black sea bass, a 12.5-inch (31.75-cm) minimum size, a 25-fish possession limit, and open seasons of May 22 through October 11 and November 1 through December 31. The status quo alternative is: (1) For summer flounder, conservation equivalency, with precautionary default measures of a 20-inch (50.8-cm) minimum fish size, a 2-fish possession limit, and an open season of May 1 through September 30; (2) for scup and black sea bass, the same as the no action alternative. The proposed alternative is: (1) For summer flounder, the same as the status quo alternative; (2) for scup, a 10.5-inch (26.67-cm) minimum fish size, a 10-fish possession limit, and an open season of January 1 through December 31; and (3) for black sea bass, a 12.5-inch (31.75-cm) minimum fish size and a 15-fish possession limit for an open season of January 1 through February 28, and a 12.5-inch (31.75-cm) minimum fish size and a 25-fish possession limit for open seasons of May 19 through October 14 and November 1 through December 31.

The impacts of the alternatives on small entities (i.e., federally permitted party/charter vessels in each state in the Northeast region) were analyzed, assessing potential changes in gross revenues for all 18 combinations ofalternatives proposed. Although NMFS's RFA guidance recommends assessing changes in profitability as a result of proposed measures, the quantitative impacts were instead evaluated using expected changes in party/charter vessel revenues as a proxy for profitability. This is because reliable cost and revenue information is not available for charter/party vessels at this time. Without reliable cost and revenue data, profits cannot be discriminated from gross revenues. As reliable cost data become available, impacts to profitability can be more accurately forecast. Similarly, changes to long-term solvency were not assessed, due both to the absence of cost data and because the recreational management measures change annually according to the specification-setting process. Effects of the various management measures were analyzed by employing quantitative approaches, to the extent possible. Where quantitative data were not available, qualitative analyses were utilized.

Because the proposed action is less restrictive than the other alternatives considered and provides the most opportunity for recreational fishing, the affected regulated entities are expected to be able to maximize fishery-related revenue under the preferred alternative relative to the non-preferred alternatives. The preferred alternative for scup would open the fishing season from June 6-September 26 to all year, and the preferred alternative for black sea bass would increase the summer season from May 22-October 11 to May 19-October 14, plus provide for a two month season in January-February 2013. For summer flounder, the preferred alternative for conservation equivalency is expected to increase fishing opportunities because, under the Commission's plan, all states but one (Delaware) are authorized to increase landings in 2012. The Council and NMFS did not consider any alternatives that would provide additional fishing opportunities because any such alternative would increase the risk of the fishery exceeding the recreational harvest limit, which could result in overfishing the stock and/or exceeding the annual catch limit. This would be contrary to the goals and objectives of the Magnuson-Stevens Act.

There are no new reporting or recordkeeping requirements contained in any of the alternatives considered for this action.

(a) The Regional Administrator has determined that the recreational fishing measures proposed to be implemented by Massachusetts through North Carolina for 2012 are the conservation equivalent of the season, minimum fish size, and possession limit prescribed in§§ 648.105, 648.104(b), and 648.106(a), respectively. This determination is based on a recommendation from the Summer Flounder Board of the Atlantic States Marine Fisheries Commission.

(b) Federally permitted vessels subject to the recreational fishing measures of this part, and other recreational fishing vessels subject to the recreational fishing measures of this part and registered in states whose fishery management measures are not determined by the Regional Administrator to be the conservation equivalent of the season, minimum size, and possession limit prescribed in §§ 648.105, 648.104(b) and 648.106(a), respectively, due to the lack of, or the reversal of, a conservation equivalent recommendation from the Summer Flounder Board of the Atlantic States Marine Fisheries Commission, shall be subject to the following precautionary default measures: Season—May 1 through September 30; minimum size—20.0 inches (50.80 cm); and possession limit—two fish.

3. Section 648.127 is revised to read as follows:

§ 648.127Scup recreational fishing season.

Fishermen and vessels that are not eligible for a moratorium permit under § 648.4(a)(6), may possess scup year-round, subject to the possession limit specified in § 648.128(a). The recreational fishing season may be adjusted pursuant to the procedures in § 648.122.

4. In § 648.128, paragraph (a) is revised to read as follows:

§ 648.128Scup possession restrictions.

(a)Party/Charter and recreational possession limits.No person shall possess more than 20 scup in, or harvested from, the EEZ unless that person is the owner or operator of a fishing vessel issued a scup moratorium permit, or is issued a scup dealer permit. Persons aboard a commercial vessel that is not eligible for a scup moratorium permit are subject to this possession limit. The owner, operator, and crew of a charter or party boat issued a scup moratorium permit are subject to the possession limit when carrying passengers for hire or when carrying more than five crew members for a party boat, or more than three crew members for a charter boat. This possession limit may be adjusted pursuant to the procedures in § 648.122.

5. In § 648.145, paragraph (a) is revised to read as follows:

§ 648.145Black sea bass possession limit.

(a) From January 1 through February 29, no person shall possess more than 15 black sea bass in, or harvested from, the EEZ unless that person is the owner or operator of a fishing vessel issued a black sea bass moratorium permit, or is issued a black sea bass dealer permit. From May 19 through October 14, and from November 1 through December 31, no person shall possess more than 25 black sea bass in, or harvested from, the EEZ unless that person is the owner or operator of a fishing vessel issued a black sea bass moratorium permit, or is issued a black sea bass dealer permit. Persons aboard a commercial vessel that is not eligible for a black sea bass moratorium permit may not retain more than 15 black sea bass from January 1 through February 29, or more than 25 black sea bass from May 19 through October 14 and from November 1 through December 31. The owner, operator, and crew of a charter or party boat issued a black sea bass moratorium permit are subject to the possession limit when carrying passengers for hire or when carrying more than five crew members for a party boat, or more than three crew members for a charter boat. This possession limit may be adjusted pursuant to the procedures in § 648.142.

6. Section 648.146 is revised to read as follows:

§ 648.146Black sea bass recreational fishing season.

Vessels that are not eligible for a moratorium permit under § 648.4(a)(7),and fishermen subject to the possession limit specified in § 648.145(a), may possess black sea bass from January 1 through February 28, May 19 through October 14, and November 1 through December 31, unless this time period is adjusted pursuant to the procedures in § 648.142.

The FTZ Board is inviting public comment on new evidence submitted on behalf of North American Tapes, LLC (NAT), in the applicant's rebuttal to comments submitted by interested parties on the amended application requesting authority on behalf of NAT to manufacture athletic tape under FTZ procedures within FTZ 109 (76 FR 43259-43260, 7-20-2011; Amendment—77 FR 13263-13264, 3-6-2012). The rebuttal comments submitted on April 18, 2012, on behalf of NAT contained new evidence on which there has not been a chance for public comment. The comment period on the new evidence is open through May 30, 2012 to allow interested parties to comment on the new evidence in the applicant's rebuttal submission. Submissions shall be addressed to the Board's Executive Secretary at the following address: Office of the Executive Secretary, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002.

The Department of Commerce (the Department) is aligning the final determination in this countervailing duty (CVD) investigation of crystalline silicon photovoltaic cells, whether or not assembled into modules (solar cells) from the People's Republic of China (PRC) with the final determination in the companion antidumping duty (AD) investigation.

On November 8, 2011, the Department initiated the AD and CVD investigations of solar cells from the PRC.1On March 26, 2012, the Department published the preliminary affirmative CVD determination pertaining to solar cells from the PRC.2On March 27, 2012, the petitioner, SolarWorld Industries America, Inc., timely requested alignment of the deadline for the final CVD determination with the deadline for the final determination in the companion AD investigation of solar cells from the PRC, in accordance with section 705(a)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(b)(4)(i) and 210(i).

Because the AD and CVD investigations were initiated simultaneously and involve the same class or kind of merchandise from the same country, we are aligning the deadline for the final CVD determination of solar cells from the PRC with the deadline for the final determination in the companion AD investigation of solar cells from the PRC, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4)(i). The final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than July 30, 2012, unless postponed.

This notice is issued and published pursuant to section 705(a)(1) of the Act.

The Department of Commerce (“the Department”) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with March anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.

The Department has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with March anniversary dates.

All deadlines for the submission of various types of information, certifications, or comments or actions by the Department discussed below refer to the number of calendar days from the applicable starting time.

Notice of No Sales

If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (“POR”), it must notify the Department within 60 days of publication of this notice in theFederal Register. All submissions must be filed electronically athttp://iaaccess.trade.govin accordance with 19 CFR 351.303.See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures,76 FR 39263 (July 6, 2011). Such submissions are subject to verification in accordance with section 782(i) of the Tariff Act of 1930, as amended (“Act”). Further, in accordance with 19 CFR 351.303(f)(3)(ii), a copy of each request must be served on the petitioner and each exporter or producer specified in the request.

Respondent Selection

In the event the Department limits the number of respondents for individual examination for administrative reviews, the Department intends to select respondents based on U.S. Customs and Border Protection (“CBP”) data for U.S. imports during the POR. We intend to release the CBP data under Administrative Protective Order (“APO”) to all parties having an APO within seven days of publication of this initiation notice and to make our decision regarding respondent selection within 21 days of publication of thisFederal Registernotice. The Department invites comments regarding the CBP data and respondent selection within five days of placement of the CBP data on the record of the applicable review.

In the event the Department decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

In general, the Department has found that determinations concerning whether particular companies should be “collapsed” (i.e., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, the Department will not conduct collapsing analyses at the respondent selection phase of this review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding (i.e., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to this review, if the Department determined, or continued to treat, that company as collapsed with others, the Department will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, the Department will not-collapse companies for purposes of respondent selection. Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value Questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where the Department considered collapsing that entity, complete quantity and value data for that collapsed entity must be submitted.

Deadline for Withdrawal of Request for Administrative Review

Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that the Department may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when the Department will exercise its discretion to extend this 90-day deadline, interested parties are advised that, with regard to reviews requested on the basis of anniversary months on or after August 2011, the Department does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance has prevented it from submitting a timely withdrawal request. Determinations by the Department to extend the 90-day deadline will be made on a case-by-case basis.

Separate Rates

In proceedings involving non-market economy (“NME”) countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, the Department analyzes each entity exporting the subject merchandise under a test arising from theFinal Determination of Sales at Less Than Fair Value: Sparklers from the People's Republic of China,56 FR 20588 (May 6, 1991), as amplified byFinal Determination of Sales at Less Than Fair Value: Silicon Carbide from the People's Republic of China,59 FR 22585 (May 2, 1994). In accordance with the separate rates criteria, the Departmentassigns separate rates to companies in NME cases only if respondents can demonstrate the absence of bothde jureandde factogovernment control over export activities.

All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, the Department requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on the Department's Web site athttp://www.trade.gov/iaon the date of publication of thisFederal Registernotice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to the Department no later than 60 calendar days after publication of thisFederal Registernotice. The deadline and requirement for submitting a Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

Entities that currently do not have a separate rate from a completed segment of the proceeding1should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name,2should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Status Application will be available on the Department's Web site athttp://www.trade.gov/iaon the date of publication of thisFederal Registernotice. In responding to the Separate Rate Status Application, refer to the instructions contained in the application. Separate Rate Status Applications are due to the Department no later than 60 calendar days of publication of thisFederal Registernotice. The deadline and requirement for submitting a Separate Rate Status Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

1Such entities include entities that have not participated in the proceeding, entities that were preliminarily granted a separate rate in any currently incomplete segment of the proceeding (e.g.,an ongoing administrative review, new shipper review,etc.) and entities that lost their separate rate in the most recently complete segment of the proceeding in which they participated.

2Only changes to the official company name, rather than trade names, need to be addressed via a Separate Rate Application. Information regarding new trade names may be submitted via a Separate Rate Certification.

For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

Initiation of Reviews

In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than March 31, 2013.

4The company name listed below was misspelled in the initiation notice that published on March 30, 2012 (77 FR 19179). The correct spelling of the company is listed in this notice.

5In the initiation notice that published on March 30, 2012 (77 FR 19179), covering cases with the February anniversary dates, the Department inadvertently stated that it had received a timely request to revoke in part the antidumping duty order on Certain Frozen Warmwater Shrimp from the PRC with respect to one exporter, however, the Department actually received timely requests with respect to two exporters.

6If one of the above-named companies does not qualify for a separate rate, all other exporters of Glycine from the PRC who have not qualified for a separate rate are deemed to be covered by this review as part of the single PRC entity of which the named exporters are a part.

7If the above-named company does not qualify for a separate rate, all other exporters of Sodium Hexametaphosphate from the PRC who have not qualified for a separate rate are deemed to be covered by this review as part of the single PRC entity of which the named exporters are a part.

8In the initiation notice that published on March 30, 2012 (77 FR 19179), covering cases with February anniversary dates, the Department inadvertently did not note that it had received timely requests to revoke in part the antidumping duty order on Certain Frozen Warmwater Shrimp from Vietnam with respect to two exporters.

During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine, consistent withFAG Italiav.United States,291 F.3d 806 (Fed Cir. 2002), as appropriate, whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the period of review.

Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305. On January 22, 2008, the Department publishedAntidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures,73 FR 3634 (January 22, 2008). Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that the meet the requirements of these procedures (e.g.,the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.Seesection 782(b) of the Act. Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives in all segments of any antidumping duty or countervailing duty proceedings initiated on or after March 14, 2011.See Certification of Factual Information to Import Administration During Antidumping and Countervailing Duty Proceedings: Interim Final Rule,76 FR 7491 (February 10, 2011) (“Interim Final Rule”), amending 19 CFR 351.303(g)(1) and (2). The formats for the revised certifications are provided at the end of theInterim Final Rule.The Department intends to reject factual submissions in any proceeding segments initiated on or after March 14, 2011 if the submitting party does not comply with the revised certification requirements.

These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).

On December 1, 2011, the Department published in theFederal Registera notice announcing the opportunity to request an administrative review of the antidumping duty order on certain hot-rolled carbon steel flat products from India for the period December 1, 2010, through November 30, 2011.See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review,76 FR 74773, 74774 (December 1, 2011).

On December 30, 2011, and January 3, 2012, Nucor Corporation and U.S. Steel Corporation (collectively, “Petitioners”) timely requested that the Department conduct an administrative review of Essar Steel Limited (“Essar”), Ispat Industries Limited (“Ispat”), JSW Steel Limited (“JSW”), and Tata Steel Limited (“Tata”). Pursuant to these requests and in accordance with 19 CFR 351.221(c)(1)(i), the Department published a notice initiating the administrative review of Essar, Ispat, JSW, and Tata.See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part,77 FR 4759 (January 31, 2012).

On January 31, 2012, the Department placed on the record and invited interested parties to comment on U.S. Customs and Border Protection (“CBP”) data, which the Department stated it would use for respondent selection in the instant review.SeeMemorandum to the File from George McMahon, Senior International Trade Analyst, through Melissa Skinner, Office Director, concerning “Certain Hot Rolled Carbon Steel Flat Products from India: Customs and Border Protection Data for Selection of Respondents for Individual Review,” dated January 31, 2012. We received no comments from interested parties on the CBP data.

On February 1, 7, 14, and 15, 2012, JSW, Tata, Essar, and Ispat, respectively, submitted letters informing the Department that they did not make shipments of subject merchandise to the United States during the period of review.

On March 7, 2012 and March 29, 2012, respectively, Nucor Corporation and U.S. Steel Corporation timely withdrew their respective requests for review of Essar, Ispat, JSW, and Tata.

Rescission of Review

Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw therequest within 90 days of the date of publication of the notice of initiation of the requested review. As noted above, Petitioners withdrew their respective requests for review of Essar, Ispat, JSW, and Tata within 90 days of the date of publication of the notice of initiation. Moreover, no other interested party requested an administrative review of these respondents. Therefore, in accordance with 19 CFR 351.213(d)(1) and consistent with our practice, we are rescinding this review with respect to Essar, Ispat, JSW, and Tata, and in its entirety.1

The Department will instruct CBP to assess antidumping duties on all appropriate entries. For Essar, Ispat, JSW, and Tata, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions to CBP 15 days after the date of publication of this notice of rescission of administrative review.

Notification to Importers

This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent increase in antidumping duties by the amount of antidumping and/or countervailing duties reimbursed.

Notification Regarding Administrative Protective Order

This notice serves as a final reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under an APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

This notice is issued and published in accordance with sections751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

On October 3, 2011, the U.S. Department of Commerce (“Department”) published a notice of initiation of the administrative review of the antidumping duty order on corrosion-resistant carbon steel flat products from the Republic of Korea, covering the period August 1, 2010, to July 31, 2011.See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part,76 FR 61076 (October 3, 2011). The preliminary results of this review are currently due no later than May 2, 2012.

Extension of Time Limit of Preliminary Results

Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires that the Department make a preliminary determination within 245 days after the last day of the anniversary month of an order for which a review is requested. Section 751(a)(3)(A) of the Act further states that if it is not practicable to complete the review within the time period specified, the administering authority may extend the 245-day period to issue its preliminary results to up to 365 days.

We determine that completion of the preliminary results of this review within the 245-day period is not practicable. Additional time is needed to gather and analyze a significant amount of information pertaining to sales practices, manufacturing costs and corporate relationships pertaining to each company participating in the review. Given the number and complexity of issues in this case, in accordance with section 751(a)(3)(A) of the Act, we are fully extending by 120 days the time period for issuing the preliminary results of review. Therefore, the preliminary results are now due no later than August 30, 2012. The final results continue to be due 120 days after publication of the preliminary results.

This notice is published pursuant to sections 751(a)(3)(A) and 777(i)(1) of the Act.

Due to the mounting costs of publishing notices in theFederal Registerand widespread access to the internet, Import Administration intends to modify the manner in which its determinations in antidumping and countervailing duty proceedings are made available to the public. The content of many of Import Administration'sFederal Registernotices will be reduced, with much of the information previously included in ourFederal Registernotices being made available to the public in separate memoranda published on Import Administration's Web site. Extension notices for preliminary and final results of reviews and certain other notices will no longer be published in theFederal Register.

Pursuant to sections 703(c)(2), 733(c)(3), 751(a)(1), 751(b)(1), 751(c)(2), and 777(i)(1) of the Tariff Act of 1930 as amended (“the Act”), Import Administration (IA) is required to publish certain notices in theFederal Register(FR). Following review of the requirements of the Act and our regulations, we have identified ways to shorten the length of many of our FR publications while also making available to the public and interested parties all pertinent information regarding our decisions. In addition, as neither the Act nor the Department of Commerce (“Department”) regulations require publication of extension notices for the preliminary and final results of reviews conducted under section 751 of the Act, we will no longer publish such notices. Further, IA will cease publishing a list of pending scope decisions in its quarterly scope ruling publication and will cease publishing an Advance Notification of Sunset Reviews when no such review is scheduled for initiation the following month.

These modifications are in line with the modification IA adopted in 2000, when it reduced the size of FR notices for final determinations and results of review by developing Issues and Decision Memoranda that now regularly accompany FR notices.See Notice of Reduction in the Size of Antidumping/Countervailing DutyFederal RegisterNotices,65 FR 3654 (January 24, 2000). The proven success of that modification, and the fact that interested parties now accept that as the standard for the final determinations and results of review, inform the decision to adopt these changes.

Outside parties and the public at large will continue to have access to all significant information that historically has been included in our FR notices. With the exception of the Advance Notification of Sunset Reviews, when no such review is scheduled for initiation the following month, and pending scope determinations, the information that we are henceforth omitting from the FR notices will be transferred to other memoranda, included in disclosure packages, and published on IA's Web site.

Modifications

IA has determined that it will no longer publish extension notices for preliminary and final results of reviews, as there are no statutory or regulatory requirements for doing so and the financial burden outweighs the benefits associated with their publication. Rather, the Department will place a memorandum extending the deadline on the official case file which, when the service becomes available, will be accessible to parties on IA ACCESS, athttp://iaaccess.trade.gov. In addition, parties and the public will be informed of upcoming deadlines and any extensions associated with these deadlines in a calendar published on IA's Web site.

IA will cease publishing our notices of Advance Notification of Sunset Review when no such reviews are scheduled for initiation in the following month. IA has also determined to cease publishing a list of pending scope inquiries in its quarterly publication of scope decisions.

All other notices will continue to be published in the FR, in a modified and condensed format. IA will continue to include in its published notices fundamental case information (e.g.,segment of proceeding, an abbreviated scope description, period of review, summary of findings, summary of methodology, names of exporters/producers subject to the proceeding, margins calculated, notification of disclosure and public comment, notifications of assessment and cash deposit instructions, and a reminder of any deadlines associated with the notice's publication) in accordance with the requirements of the Act. For preliminary and final determinations of investigations, and antidumping and countervailing duty orders, IA will include the entire scope discussion in the FR, and not an abbreviated format. Abbreviated scope descriptions in other notices will provide a reference to the location of the full scope description. All other information will be transferred to separate memoranda. For example, for preliminary results of an administrative review, IA will issue a memorandum to accompany the FR notice, which will include the complete, detailed discussion of our margin calculation methodology, significant case issues, and background/history of the order. The memorandum will be a public document released to interested parties and published on IA's Web site. External services, such as Lexis and Westlaw, may also make the memorandum available to their clients in an electronically searchable format. In the coming months, IA will create such memoranda for most notices that will continue to be published in the FR and identify the content that will remain in the FR notices and the content that will be included in the separate memorandum.

Implementation

The modifications described in this notice will be incrementally implemented. Beginning May 15, 2012, IA will no longer publish extension notices in the FR. Rather, these extensions will be published in calendar form on the IA Web site, available athttp://ia.ita.doc.gov/frn/. On that date, IA will stop publishing Advance Notification of Sunset Reviews when no such review is scheduled for initiation the following month. The next quarterly scope decision will no longer contain a list of pending scope decisions. Beginning September 1, 2012, abbreviated notices for all preliminary determinations and preliminary results of review will be published in the FR, while the memorandum accompanying each notice that includes the background, methodology, and additional content will be adopted through the notice's publication and posted on the IA Web site, available athttp://ia.ita.doc.gov/frn/ext/.

Finally, we anticipate that other IA notices will be published in abbreviated format in the near future, following implementation of the changes discussed in this notice.

On October 25, 2011, the National Institute of Standards and Technology (NIST) published a notice of a public meeting, which was held on November 8, 2011, to explore the feasibility of establishing a NIST/Industry Consortium on Concrete Rheology: Enabling Metrology (CREME)”. The notice stated that membership fees for participation in the CREME consortium would be Twenty-five Thousand ($25,000) per year. As a result of the November 8, 2011, publicmeeting, revisions have been made to the membership fee structure.

DATES:

This notice is effective on April 30, 2012.

ADDRESSES:

Questions about joining the consortium should be sent to Chiara Ferraris at the National Institute of Standards and Technology; 100 Bureau Drive; MS 8615; Gaithersburg, MD 20899-8615.

The goal of the CREME consortium is to predict the pumpability of a grout/mortar or a concrete from the rheological properties of the materials and the geometry/material of the pipe. This goal will be achieved by developing test methods and models to measure and predict the performance parameters of grout. It is expected that the conclusions obtained for grout could be extrapolated for concrete. To move these ideas into practice and to engage industry, test bed facilities and quality control test methods for the field will be developed at NIST. The consortium will be administered by NIST. Consortium planning, research and development will be conducted by NIST staff along with at least one technical representative from each participating member company. Each member of the consortium will be required to sign a Cooperative Research and Development Agreement (“CRADA”) with NIST.

At the November 8, 2011 public meeting, organizations interested in participating in the CREME Consortium discussed membership fees and agreed to the following revisions to the membership fee structure. Initial membership fees will be Twenty Five Thousand Dollars ($25,000) per year payable by Member to NIST at the time of CRADA execution and annually thereafter, or an in-kind contribution, equitable in value and mutually acceptable to NIST and Member. In recognition of the contributions made and risks taken by the initial Consortium Members, the membership fee for Consortium Members who join after the first year will be Fifty Thousand Dollars ($50,000) or mutually acceptable to NIST and Member in-kind contribution the first year and Twenty Five Thousand Dollars ($25,000) or mutually acceptable to NIST and Member in-kind contribution each year thereafter.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice of receipt of an application for an exempted fishing permit; request for comments.

SUMMARY:

NMFS announces the receipt of an application for an exempted fishing permit (EFP) from the South Carolina Aquarium. If granted, the EFP would authorize the South Carolina Aquarium to collect, with certain conditions, various species of reef fish, crabs, and lobsters in Federal waters off South Carolina and North Carolina. The specimens would be used in educational exhibits displaying South Carolina native species at the South Carolina Aquarium located in Charleston, SC.

DATES:

Comments must be received no later than 5 p.m., e.t., on May 30, 2012.

ADDRESSES:

You may submit comments on the application by either of the following methods:

•Email: Kate.Michie@noaa.gov;include in the subject line of the email comment the following document identifier: South Carolina Aquarium EFP.

The project proposes to use vertical hook-and-line gear with artificial and natural baits, black sea bass pots, spiny lobster traps, golden crab traps, habitat traps, octopus traps, dip nets, and bait traps (bait traps would be used and tended while SCUBA diving). This EFP would authorize sampling operations to be conducted on four vessels designated by the South Carolina Aquarium including: F/V ON THE CLOCK SC-5264-BW; F/V CUB SCOUT SC-9288-BF; F/V MISTRESS SC-5326-BS; and a 25 ft (7.62 m) Parker NC5836P. The specimens would be opportunistically collected year-round for a period of 5 years, commencing on July 2, 2012. This EFP would not authorize the collection of species with an annual catch limit of zero (red snapper, warsaw grouper, speckled hind, goliath grouper, and Nassau grouper).

The overall intent of the project is to incorporate South Carolina native species into educational exhibits at the South Carolina Aquarium. The aquarium uses these displays of native South Carolina species to teach the public about stewardship and habitat preservation.

NMFS finds this application warrants further consideration. Based on apreliminary review, NMFS intends to issue an EFP. Possible conditions the agency may impose on this permit, if it is granted, include but are not limited to, a prohibition of collection of specimens within marine protected areas, marine sanctuaries, special management zones, or artificial reefs without additional authorization. Additionally, NMFS prohibits the possession of Nassau grouper, goliath grouper, red snapper, speckled hind or warsaw grouper, and requires any sea turtles taken incidentally during the course of fishing or scientific research activities to be handled with due care to prevent injury to live specimens, observed for activity, and returned to the water.

A final decision on issuance of the EFP will depend on NMFS' review of public comments received on the application, consultations with the affected states, the Council, and the U.S. Coast Guard, as well as a determination that the EFP is consistent with all applicable laws.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice of public meeting.

SUMMARY:

This notice announces the date, time, and location of the public meeting being held prior to the 64th annual International Whaling Commission (IWC) meeting.

DATES:

The public meeting will be held June 5, 2012, at 2 p.m.

ADDRESSES:

The meeting will be held in the NOAA Science Center Room, 1301 East-West Highway, Silver Spring, MD 20910.

FOR FURTHER INFORMATION CONTACT:

Melissa Andersen, 301-427-8385.

SUPPLEMENTARY INFORMATION:

The Secretary of Commerce is responsible for discharging the domestic obligations of the United States under the International Convention for the Regulation of Whaling, 1946. The U.S. IWC Commissioner has responsibility for the preparation and negotiation of U.S. positions on international issues concerning whaling and for all matters involving the IWC. The U.S. IWC Commissioner is staffed by the Department of Commerce and assisted by the Department of State, the Department of the Interior, the Marine Mammal Commission, and other U.S. Government agencies.

A draft agenda for the annual IWC meeting should be posted on the IWC Secretariat's Web site athttp://www.iwcoffice.orgby late May.

NOAA will a hold public meeting to discuss the tentative U.S. positions for the upcoming IWC meeting. Because the meeting will address U.S. positions, the substance of the meeting must be kept confidential. Any U.S. citizen with an identifiable interest in U.S. whale conservation policy may participate, but NOAA reserves the authority to inquire about the interests of any person who appears at the meeting and to determine the appropriateness of that person's participation. In particular, persons who represent foreign interests may not attend. These stringent measures are necessary to protect the confidentiality of U.S. negotiating positions.

The June 5, 2012, meeting will be held in the NOAA Science Center Room, 1301 East-West Highway, Silver Spring, MD 20910. Photo identification is required to enter the building.

Special Accommodations

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Melissa Andersen,Melissa.Andersen@noaa.govor 301-427-8385, by May 23, 2012.

NMFS has received an application from the U.S. Navy (Navy) for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to construction activities as part of a pile replacement project. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to the Navy to take, by Level B Harassment only, six species of marine mammals during the specified activity.

DATES:

Comments and information must be received no later than May 30, 2012.

ADDRESSES:

Comments on the application should be addressed to Tammy C. Adams, Acting Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910-3225. The mailbox address for providing email comments isITP.Laws@noaa.gov.NMFS is not responsible for email comments sent to addresses other than the one provided here. Comments sent via email, including all attachments, must not exceed a 10-megabyte file size.

Instructions:All comments received are a part of the public record and will generally be posted tohttp://www.nmfs.noaa.gov/pr/permits/incidental.htmwithout change. All Personal Identifying Information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

An electronic copy of the application containing a list of the references used in this document may be obtained by writing to the address specified above, telephoning the contact listed below (seeFOR FURTHER INFORMATION CONTACT), or visiting the Internet at:http://www.nmfs.noaa.gov/pr/permits/incidental.htm.Documents cited in thisnotice may also be viewed, by appointment, during regular business hours, at the aforementioned address.

FOR FURTHER INFORMATION CONTACT:

Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401.

SUPPLEMENTARY INFORMATION:Background

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “* * * an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

Summary of Request

NMFS received an application on March 8, 2012 from the Navy for the taking of marine mammals incidental to pile removal and removal in association with a pile replacement project in the Hood Canal at Naval Base Kitsap at Bangor, WA (NBKB). This pile replacement project is proposed to occur between July 16, 2012 and July 15, 2013. This IHA would cover the second and final year of this project; NMFS previously issued an IHA for the first year of work associated with this project (76 FR 30130; May 24, 2011). In-water work, including all pile removal activities, would occur only within an approved window from July 16-February 15. Seven species of marine mammals are known from the waters surrounding NBKB: Steller sea lions (Eumetopias jubatus), California sea lions (Zalophus californianus), harbor seals (Phoca vitulina), killer whales (Orcinus orca;transient type only), Dall's porpoises (Phocoenoides dalli), harbor porpoises (Phocoena phocoena), and the humpback whale (Megaptera novaeangliae). These species may occur year-round in the Hood Canal, with the exception of the Steller sea lion, which is present only from fall to late spring (October to mid-April), and the California sea lion, which is not present during part of summer (late June through July). Additionally, while the Southern resident killer whale (listed as endangered under the Endangered Species Act [ESA]) is resident to the inland waters of Washington and British Columbia, it has not been observed in the Hood Canal in over 15 years and was therefore excluded from further analysis.

NBKB provides berthing and support services for OHIO Class ballistic missile submarines (SSBN), also known as TRIDENT submarines. The Navy proposes to complete necessary repairs and maintenance at the Explosive Handling Wharf #1 (EHW-1) facility at NBKB as part of a pile replacement project to restore and maintain the structural integrity of the wharf and ensure its continued functionality to support necessary operational requirements. The EHW-1 facility, constructed in 1977, has become compromised due to the deterioration of the wharf's existing piling sub-structure. Under the proposed action, ninety-six 24-in (0.6-m) diameter concrete piles, twenty-one 12-in (0.3-m) diameter steel fender piles, eight 16-in (0.4-m) diameter steel falsework piles, and one 24-in diameter steel fender pile will be removed. The proposed action represents the remainder of work planned for the initial 2-year rehabilitation plan, following the work that was completed in 2011. The Navy may continue rehabilitation work at EHW-1 in the long-term, but has no immediate plans to do so. All concrete piles would be removed via pneumatic chipping or similar method. All steel piles would be removed via vibratory hammer or direct pull; however, the analysis in this document assumes that all piles would be removed via vibratory hammer. No pile installation—and therefore no impact pile removal—is proposed for this action.

For pile removal activities, the Navy used NMFS-promulgated thresholds for assessing impacts (NMFS, 2005b, 2009), outlined later in this document. The Navy used recommended spreading loss formulas (the practical spreading loss equation for underwater sounds and the spherical spreading loss equation for airborne sounds) and empirically-measured source levels from 18- to 30-in (0.5- to 0.8-m) diameter steel pile removal events, or concrete pile removal events using similar methodology, to estimate potential marine mammal exposures. Predicted exposures are outlined later in this document. The calculations predict that no Level A harassments would occur associated with pile removal activities, and that as many as 1,416 Level B harassments may occur during the pile replacement project from generation of underwater sound. No incidents of harassment were predicted from airborne sounds associated with pile removal.

Description of the Specified Activity

NBKB is located on the Hood Canal approximately 20 miles (32 km) west of Seattle, Washington (see Figures 2-1 through 2-3 in the Navy's application). NBKB provides berthing and support services for OHIO Class ballistic missile submarines (SSBN), also known as TRIDENT submarines. The Navy proposes a pile replacement project to maintain the structural integrity of EHW-1 and ensure its continued functionality to support operational requirements of the TRIDENT submarine program. The proposed actions with the potential to cause harassment of marine mammals within the waterways adjacent to NBKB, under the MMPA, are vibratory and pneumatic chipping pile removal operations associated with the pile replacement project. The proposed activities that would be authorized by this IHA would occur between July 16, 2012 and February 15, 2013. All in-water construction activities within the HoodCanal are only permitted during July 16-February 15 in order to protect spawning fish populations.

As part of the Navy's sea-based strategic deterrence mission, the Navy Strategic Systems Programs directs research, development, manufacturing, test, evaluation, and operational support for the TRIDENT Fleet Ballistic Missile program. Maintenance and development of necessary facilities for handling of explosive materials is part of these duties. The proposed action includes the removal of 126 steel and concrete piles at EHW-1. Please see Figures 1-1 through 1-3 of the Navy's application for conceptual and schematic representations of the work proposed for EHW-1. Of the piles requiring removal, 96 are 24-in (0.6-m) diameter hollow pre-cast concrete piles which will be excised down to the mud line. One additional 24-in steel fender pile, twenty-one 12-in (0.3-m) steel fender piles, and eight 16-in (0.4-m) steel falsework piles will be extracted using a vibratory hammer or direct pull. Also included in the repair work is removal of the fragmentation barrier and walkway, construction of new cast-in-place pile caps (concrete formwork may be located below Mean Higher High Water [MHHW]), installation of the pre-stressed superstructure, installation of four sled-mounted cathodic protection (CP) systems, and installation or re-installation of related appurtenances.

During the first year of work, conducted under an IHA issued by NMFS (76 FR 30130; May 24, 2011), the Navy completed the following work:

• Removal of ten steel fender piles (eight 12-in diameter piles and two 24-in diameter piles) and associated fender system components. A fender pile, typically set beside slips or wharves, guides approaching vessels and is driven so as to yield slightly when struck in order to lessen the shock of contact. The fender system components attach the fender piles to the structure, and are above the water line.

In addition, the Navy plans to complete construction of six cast-in-place concrete pile caps in early 2012. Pile caps are situated on the tops of the steel piles located directly beneath the structure, and function as a load transfer mechanism between the superstructure and the piles. This work is above-water, and does not have the potential to impact marine mammals.

During the 2012-13 in-water work season, the Navy proposes to complete the 2-year rehabilitation project, including the following work:

• Removal of 126 steel and concrete piles, as described previously.

• Removal of the concrete fragmentation barrier and walkway, used to get from the Wharf Apron to the Outboard Support. These structures will likely be removed by cutting the concrete into sections (potentially three or four in total) using a saw, or other equipment, and removed using a crane. The crane will lift the sections from the existing piles and place them on a barge.

• Installation of a pre-stressed concrete superstructure. The superstructure is the concrete deck of the wharf found above, or supported by, the caps or sills, including the deck, girders, and stringers.

• Installation of three sled-mounted passive CP systems. The passive CP system is a metallic rod or anode that is attached to a metal object to protect it from corrosion. The anode is composed of a more active metal than that on which it is mounted and is more easily oxidized, thus corroding first and acting as a barrier against corrosion for the object to which it is attached. This system would be banded to the steel piles to prevent metallic surfaces of the wharf from corroding due to the saline conditions in Hood Canal.

• Installation or re-installation of related appurtenances, the associated parts of the superstructure that connect the superstructure to the piles. These pieces include components such as bolts, welded metal hangers and fittings, brackets, etc.

Concrete piles would be removed with a pneumatic chipping hammer or another tool capable of cutting through concrete. A pneumatic chipping hammer is similar to a jackhammer or other similar electric power tool, but uses compressed air instead of electricity, and consists of a steel piston that is reciprocated in a steel barrel. On its forward stroke the piston strikes the end of the chisel, reciprocating at a rate such that the chisel edge vibrates against the concrete with enough force to fragment or splinter the pile. When possible, piles will be first scored by a diver using a smaller pneumatic hammer, with the pile then moved slightly back and forth to break at the score. Remaining parts of the pile will be chipped away with the larger pneumatic hammer. If the scoring/breaking technique is not feasible, the entire base of the pile will be chipped away with a pneumatic hammer such that the pile may be removed. Concrete debris will be captured as practicable using debris curtains/sheeting and removed from the project area.

The installation of the concrete pile caps, the concrete superstructure, and sled-mounted passive CP systems will occur out of the water and on the tops of the piles or attached to the wharf's superstructure. The removal of the fragmentation barrier and walkway will occur above the water with best management practices in place to prevent material from entering the water. While sound transmission from these activities could occur and enter the water, this is expected to be minimal, and above-water work is not considered to have the potential to impact marine mammals. However, these activities will occur during the in-water work window of July 16 to February 15 to minimize the potential for impacts to other listed species, particularly fish. The Navy will conduct acoustic monitoring for pneumatic chipping only—acoustic monitoring was conducted in 2011 for vibratory pile installation at NBKB—and will monitor the presence and behavior of marine mammals during vibratory pile removal and pneumatic chipping activities.

The Navy estimates that steel pile removal will occur at an average rate of two piles per day, and is expected to require no more than 1 hour per pile. It is estimated that concrete pile removal will occur at a rate of three piles per day, and is expected to take approximately 2 hours per pile. This results in an estimated maximum of 2 hours per day of steel pile removal, and potentially 6 hours per day of pneumatic chipping. These two activities would likely not occur on the same day, however. On the basis of these estimates, the Navy states that steel pile removal would require 15 days and concrete pile removal would require an additional 32 days. The analysis contained herein is thus based upon these numbers, and assumes that (1) all marine mammals available to be incidentally taken within the relevant area would be; and (2) individual marine mammals may only be incidentally taken once in a 24-hour period—for purposes of authorizing specified numbers of take—regardless of actual number of exposures in that period.

The number of construction barges (derrick and material) on site at any one time would vary depending on the type of construction taking place. Tug boats would tow barges to and from the construction site and position the barges for construction activity. Tug boats would leave the site once these tasks were completed and so would not be on site for extended periods. Smaller skiff-type boats would be on site performing various functions in support ofconstruction and monitoring requirements.

Description of Sound Sources

Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in Hz or cycles per second. Wavelength is the distance between two peaks of a sound wave; lower frequency sounds have longer wavelengths than higher frequency sounds and attenuate more rapidly in shallower water. Amplitude is the height of the sound pressure wave or the `loudness' of a sound and is typically measured using the decibel (dB) scale. A dB is the ratio between a measured pressure (with sound) and a reference pressure (sound at a constant pressure, established by scientific standards). It is a logarithmic unit that accounts for large variations in amplitude; therefore, relatively small changes in dB ratings correspond to large changes in sound pressure. When referring to SPLs (SPLs; the sound force per unit area), sound is referenced in the context of underwater sound pressure to 1 microPascal (μPa). One pascal is the pressure resulting from a force of one newton exerted over an area of one square meter. The source level represents the sound level at a distance of 1 m from the source (referenced to 1 μPa). The received level is the sound level at the listener's position.

Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Rms is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1975). Rms accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.

When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in all directions away from the source (similar to ripples on the surface of a pond), except in cases where the source is directional. The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones. Underwater sound levels (`ambient sound') are comprised of multiple sources, including physical (e.g., waves, earthquakes, ice, atmospheric sound), biological (e.g., sounds produced by marine mammals, fish, and invertebrates), and anthropogenic sound (e.g., vessels, dredging, aircraft, construction). Even in the absence of anthropogenic sound, the sea is typically a loud environment. A number of sources of sound are likely to occur within Hood Canal, including the following (Richardsonet al.,1995):

•Wind and waves:The complex interactions between wind and water surface, including processes such as breaking waves and wave-induced bubble oscillations and cavitation, are a main source of naturally occurring ambient noise for frequencies between 200 Hz and 50 kHz (Mitson, 1995). In general, ambient noise levels tend to increase with increasing wind speed and wave height. Surf noise becomes important near shore, with measurements collected at a distance of 8.5 km (5.3 mi) from shore showing an increase of 10 dB in the 100 to 700 Hz band during heavy surf conditions.

•Precipitation noise:Noise from rain and hail impacting the water surface can become an important component of total noise at frequencies above 500 Hz, and possibly down to 100 Hz during quiet times.

•Biological noise:Marine mammals can contribute significantly to ambient noise levels, as can some fish and shrimp. The frequency band for biological contributions is from approximately 12 Hz to over 100 kHz.

In-water construction activities associated with the project would include vibratory pile removal and pneumatic chipping of concrete piles. The sounds produced by these activities are considered non-pulsed (defined in next paragraph) as opposed to pulsed sounds. The distinction between these two general sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (e.g., Ward, 1997 in Southallet al.,2007). Please see Southallet al.,(2007) for an in-depth discussion of these concepts.

Pulsed sounds (e.g., explosions, gunshots, sonic booms, and impact pile removal) are brief, broadband, atonal transients (ANSI, 1986; Harris, 1998) and occur either as isolated events or repeated in some succession. Pulsed sounds are all characterized by a relatively rapid rise from ambient pressure to a maximal pressure value followed by a decay period that may include a period of diminishing, oscillating maximal and minimal pressures. Pulsed sounds generally have an increased capacity to induce physical injury as compared with sounds that lack these features.

Non-pulse (intermittent or continuous sounds) can be tonal, broadband, or both. Some of these non-pulse sounds can be transient signals of short duration but without the essential properties of pulses (e.g., rapid rise time). Examples of non-pulse sounds include those produced by vessels, aircraft, machinery operations such as drilling or dredging, vibratory pile removal, and active sonar systems. The duration of such sounds, as received at a distance, can be greatly extended in a highly reverberant environment.

Vibratory hammers install or remove piles by vibrating them—thus causing liquefaction of the surrounding substrate—which then allows the piles to be more easily pushed or pulled. Vibratory hammers produce significantly less sound than impact hammers. Peak SPLs during vibratory installation may be 180 dB or greater, but are generally 10 to 20 dB lower than SPLs generated during impact pile removal of the same-sized pile (Caltrans, 2009). Rise time is slower, reducing the probability and severity of injury (USFWS, 2009), and sound energy is distributed over a greater amount of time (Nedwell and Edwards, 2002; Carlsonet al.,2001).

Ambient Sound

The underwater acoustic environment consists of ambient sound, defined as environmental background sound levels lacking a single source or point (Richardsonet al.,1995). The ambient underwater sound level of a region is defined by the total acoustical energy being generated by known and unknown sources, including sounds from both natural and anthropogenic sources. The sum of the various natural and anthropogenic sound sources at any given location and time depends notonly on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, the ambient sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardsonet al.,1995).

Airborne sound levels at NBKB vary based on location but are estimated to average around 65 dBA (A-weighted decibels) in the residential and office park areas, with traffic sound ranging from 60-80 dBA during daytime hours (Cavanaugh and Tocci, 1998). The highest levels of airborne sound are produced along the waterfront and at the ordnance handling areas, where estimated sound levels range from 70-90 dBA and may peak at 99 dBA for short durations. These higher sound levels are produced by a combination of sound sources including heavy trucks, forklifts, cranes, marine vessels, mechanized tools and equipment, and other sound-generating industrial or military activities.

Sound Thresholds

Since 1997, NMFS has used generic sound exposure thresholds to determine when an activity in the ocean that produces sound might result in impacts to a marine mammal such that a take by harassment might occur (NMFS, 2005b). To date, no studies have been conducted that examine impacts to marine mammals from pile removal sounds from which empirical sound thresholds have been established. Current NMFS practice regarding exposure of marine mammals to sound is that cetaceans and pinnipeds exposed to sound levels of 180 and 190 dB rms or above, respectively, are considered to have been taken by Level A (i.e., injurious) harassment. Behavioral harassment (Level B) is considered to have occurred when marine mammals are exposed to sounds at or above 120 dB rms for continuous sound (such as would be produced by the proposed activities), but below injurious thresholds. For airborne sound, pinniped disturbance from haul-outs has been documented at 100 dB (unweighted) for pinnipeds in general, and at 90 dB (unweighted) for harbor seals. NMFS uses these levels as guidelines to estimate when harassment may occur.

Distance to Sound Thresholds

Underwater Sound Propagation Formula—Pile removal would generate underwater noise that potentially could result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. A practical sound propagation modeling technique was used by the Navy to estimate the range from the activity to various SPL thresholds in water. This model follows a geometric propagation loss based on the distance from the pile, resulting in a 4.5 dB reduction in level for each doubling of distance from the source. In this model, the SPL at some distance away from the source (e.g., driven pile) is governed by a measured source level, minus the transmission loss of the energy as it dissipates with distance. The formula for underwater TL is:

TL = 15 * log10(R1/R2), where

R1= the distance of the modeled SPL from the pile, and

R2= the distance from the pile of the initial measurement.

The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20*log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10*log[range]). The propagation environment along the NBKB waterfront conforms to neither spherical nor cylindrical spreading; as the receiver moves away from the shoreline, the water increases in depth, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions. Since there is no available data regarding propagation loss along the NBKB waterfront, a practical spreading loss model was adopted as the most likely approximation of the sound propagation environment. Hydroacoustic monitoring results from the Navy's Test Pile Project (see 76 FR 38361; July 30, 2011) and from the first year of EHW-1 construction will be used, when available, to confirm the validity of the practical spreading model for estimating acoustic propagation in the project area.

Underwater Sound from Pile Removal—The intensity of pile removal sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. Despite a large quantity of literature regarding SPLs recorded from pile removal projects, there is a general lack of empirical data regarding vibratory pile removal and the acoustic output of chipping hammers. In order to determine reasonable SPLs and their associated affects on marine mammals that are likely to result from pile removal at NBKB, studies with similar properties to the proposed action were evaluated. Overall, studies which met the following parameters were considered: (1)Pile size and materials:Steel pipe pile removal (12- to 24-in diameter) and concrete pile removal with chipping hammer or similar method (because these tools are used to chip portions of concrete from the pile, sound output is not tied to pile size); (2)Hammer machinery:Vibratory hammer for steel piles and pneumatic chipping hammer or similar tool for concrete piles; and (3)Physical environment:Shallow depth (less than 100 ft [30 m]). Table 1 details representative SPLs that have been recorded from similar construction activities in recent years. Due to the similarity of these actions and the Navy's proposed action, these values represent reasonable SPLs which could be anticipated, and which were used in the acoustic modeling and analysis.

Based on these representative SPLs, the source levels used in this analysis are 180 dB re: 1 μPa (rms) for vibratory removal and 161 dB re: 1 μPa (rms) for pneumatic chipping, which is considered analogous to the jackhammer. Therefore, vibratory removal would produce SPLs that are below the injury threshold for pinnipeds, while SPLs resulting from pneumatic chipping are well below levels that may cause injury to any marine mammal. All calculated distances to and the total area encompassed by the marine mammal underwater sound thresholds are provided in Table 2.

The values presented in Tables 2 assume a field free of obstruction, which is unrealistic, because Hood Canal does not represent open water conditions (free field). Therefore, sounds would attenuate as they encounter land masses or bends in the canal. As a result, some of the distances and areas of impact calculated cannot actually be attained at the project area. The actual distances to the behavioral disturbance thresholds for vibratory pile removal and pneumatic chipping may be shorter than those calculated due to the irregular contour of the waterfront, the narrowness of the canal, and the maximum fetch (furthest distance sound waves travel without obstruction [i.e., line of sight]) at the project area. The actual areas encompassed by sound exceeding or reaching the 120 dB threshold are 35.9 km2and 0.6 km2for vibratory removal and pneumatic chipping, respectively. See Figures 6-1 and 6-2 of the Navy's application for a depiction of the size of areas in which each underwater sound threshold is predicted to occur at the project area due to pile removal.

Airborne Sound Propagation Formula—Pile removal can generate airborne sound that could potentially result in disturbance to marine mammals (specifically, pinnipeds) which are hauled out or at the water's surface. As a result, the Navy analyzed the potential for pinnipeds hauled out or swimming at the surface near NBKB to be exposed to airborne SPLs that could result in Level B behavioral harassment. The appropriate airborne sound threshold for behavioral disturbance for all pinnipeds, except harbor seals, is 100 dB re: 20 μPa rms (unweighted). For harbor seals, the threshold is 90 dB re: 20 μPa rms (unweighted). A spherical spreading loss model, assuming average atmospheric conditions, was used to estimate the distance to the airborne thresholds. The formula for calculating spherical spreading loss is:

TL = 20log(R1/R2)TL = Transmission lossR1= the distance of the modeled SPL from the pile, andR2= the distance from the pile of the initial measurement.

Airborne Sound from Pile Installation—As was discussed for underwater sound from pile removal, the intensity of pile removal sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. In order to determine reasonable airborne SPLs and their associated effects on marine mammals that are likely to result from pile removal at NBKB, studies with similar properties to the proposed action, as described previously, were evaluated. Table 3 details representative pile removal activities that have occurred in recent years. Due to the similarity of these actions and the Navy's proposed action, they represent reasonable SPLs which could be anticipated. Given these data, representative source levels are approximately 116.5 dB re: 20 μPa rms (unweighted) for vibratory removal and 112 dB re: 20 μPa rms (unweighted) for chipping.

The distances to the airborne thresholds were calculated with the airborne transmission loss formula presented previously. All calculated distances to and the total area encompassed by the marine mammal underwater sound thresholds are provided in Table 4.

All airborne distances are less than those calculated for underwater sound thresholds for disturbance. Protective measures would be in place out to the distances calculated for the underwater thresholds, and the distances for the airborne thresholds would be covered fully by mitigation and monitoring measures in place for underwater sound thresholds. Construction sound associated with the project would not extend beyond the disturbance zone for underwater sound that would be established to protect pinnipeds. No haul-outs or rookeries are located within the airborne harassment radii. See Figures 6-3 through 6-6 of the Navy's application for a depiction of the size of areas in which each airborne sound threshold is predicted to occur at the project area due to pile removal.

Description of Marine Mammals in the Area of the Specified Activity

There are seven marine mammal species, four cetaceans and three pinnipeds, which may inhabit or transit through the waters nearby NBKB in the Hood Canal. These include the transient killer whale, harbor porpoise, Dall's porpoise, Steller sea lion, California sea lion, harbor seal, and humpback whale. While the Southern Resident killer whale is resident to the inland waters of Washington and British Columbia, it has not been observed in the Hood Canal in over 15 years, and therefore was excluded from further analysis. The Steller sea lion and humpback whale are the only marine mammals that may occur within the Hood Canal that are listed under the ESA; the humpback whale is listed as endangered and the eastern distinct population segment (DPS) of Steller sea lion is listed as threatened. All marine mammal species are protected under the MMPA. This section summarizes the population status and abundance of these species, followed by detailed life history information. Table 5 lists the marine mammal species that occur in the vicinity of NBKB and their estimated densities within the project area during the proposed timeframe. Daily maximum abundance data only is presented for sea lions because sightings data have no defined survey area.

Table 5—Marine Mammals That May Be Present in the Hood CanalSpeciesStock abundance1Relative occurrence in

Hood Canal2

Season of occurrenceDensity during in-water work season

(individuals/km2)

Steller sea lion—Eastern U.S. DPS58,334-72,2233CommonFall to late spring (Oct to mid-April)41.2California sea lion—U.S. stock238,000CommonFall to late spring (Aug to early June)426.2Harbor seal—WA inland waters stock14,612 (CV = 0.15)CommonYear-round; resident species in Hood Canal51.31Humpback whale—CA/OR/WA stock2,043 (CV = 0.10)Extremely rareYear-round in Puget Sound60.003Killer whale—West Coast transient stock354RareYear-round70.038Dall's porpoise—CA/OR/WA stock42,000 (CV = 0.33)RareYear-round70.014Harbor porpoise—WA inland waters stock10,682 (CV = 0.38)Possible common to occasional presenceYear-round90.2501NMFS marine mammal stock assessment reports at:http://www.nmfs.noaa.gov/pr/sars/species.htm.2Common: Consistently present either year-round or during non-breeding season; Occasional: Documented at irregular intervals; Rare: Sporadic sightings not occurring on a yearly basis; Extremely rare: Generally not observed over multiple years.3Range calculated on basis of total pup counts 2006-2009 and extrapolation factors derived from vital rate parameters estimated for an increasing population.4Density for sea lions is not calculated due to the lack of a defined survey area for sightings data. Abundance calculated as the average of the maximum number of individuals present during shore-based surveys at NBKB waterfront during the in-water construction season.5Jeffrieset al.,2003; Huberet al.,2001.6Density calculated on the basis of one individual observed in Hood Canal.7Density calculated as the maximum number of individuals present at a given time during occurrences of killer whales at Hood Canal in 2003 and 2005 (London, 2006) divided by the area of Hood Canal.8Density calculated from number of individuals observed in 18 vessel-based surveys of NBKB waterfront area (Tannenbaumet al.,2009, 2011).9Density calculated from number of individuals observed during vessel-based surveys conducted during Test Pile Program and corrected for detectability (Navy, in prep.).Steller Sea Lion

Species Description—Steller sea lions are the largest members of the Otariid (eared seal) family. Steller sea lions show marked sexual dimorphism, in which adult males are noticeably larger and have distinct coloration patterns from females. Males average approximately 1,500 lb (680 kg) and 10 ft (3 m) in length; females average about 700 lb (318 kg) and 8 ft (2.4 m) in length. Adult females have a tawny to silver-colored pelt. Males are characterized by dark, dense fur around their necks, giving a mane-like appearance, and light tawny coloring over the rest of their body (NMFS, 2008a). Steller sea lions are distributed mainly around the coasts to the outer continental shelf along the North Pacific Ocean rim from northern Hokkaido, Japan through the Kuril Islands and Okhotsk Sea, Aleutian Islands and central Bering Sea, southern coast of Alaska and south to California. The population is divided into the Western and the Eastern Distinct Population Segments (DPSs) at 144° W (Cape Suckling, Alaska). The Western DPS includes Steller sea lions that reside in the central and western Gulf of Alaska, Aleutian Islands, as well as those that inhabit coastal waters and breed in Asia (e.g., Japan and Russia). The Eastern DPS extends from California to Alaska, including the Gulf of Alaska.

Status—Steller sea lions were listed as threatened range-wide under the ESA in 1990. After division into two DPSs, the western DPS was listed as endangered under the ESA in 1997, while the eastern DPS remained classified as threatened. Animals found in the Region of Activity are from the eastern DPS (NMFS, 1997a; Loughlin, 2002; Angliss and Outlaw, 2005). The eastern DPS breeds in rookeries located in southeast Alaska, British Columbia, Oregon, and California. While some pupping has been reported recently along the coast of Washington, there are no active rookeries in Washington. A final revised species recovery plan addresses both DPSs (NMFS, 2008a).

NMFS designated critical habitat for Steller sea lions in 1993. Critical habitat is associated with breeding and haul-out sites in Alaska, California, and Oregon, and includes so-called `aquatic zones' that extend 3,000 ft (900 m) seaward in state and federally managed waters from the baseline or basepoint of each major rookery in Oregon and California (NMFS, 2008a). Three major rookery sites in Oregon (Rogue Reef, Pyramid Rock, and Long Brown Rock and Seal Rock on Orford Reef at Cape Blanco) and three rookery sites in California (Ano Nuevo I, Southeast Farallon I, and Sugarloaf Island and Cape Mendocino) are designated critical habitat (NMFS, 1993). There is no designated critical habitat within the Region of Activity.

Factors that have previously been identified as threats to Steller sea lions include reduced food availability, possibly resulting from competition with commercial fisheries; incidental take and intentional kills during commercial fish harvests; subsistence take; entanglement in marine debris; disease; pollution; and harassment. Steller sea lions are also sensitive to disturbance at rookeries (during pupping and breeding) and haul-out sites.

The Recovery Plan for the Steller Sea Lion (NMFS, 2008a) states that the overall abundance of Steller sea lions in the eastern DPS has increased for a sustained period of at least three decades, and that pup production has increased significantly, especially since the mid-1990s. Between 1977 and 2002, researchers estimated that overall abundance of the eastern DPS had increased at an average rate of 3.1 percent per year (NMFS, 2008a; Pitcheret al.,2007). NMFS' most recent stock assessment report estimates that population for the eastern DPS is a minimum of 52,847 individuals; this estimate is not corrected for animals at sea, and actual population is estimated to be within the range 58,334 to 72,223 (Allen and Angliss, 2010). The minimum count for Steller sea lions in Oregon and Washington was 5,813 in 2002 (Pitcheret al.,2007; Allen and Angliss, 2010).

The abundance of the eastern DPS of Steller sea lions is increasing throughout the northern portion of its range (southeast Alaska and British Columbia), and stable or increasing in the central portion (Oregon through central California). Surveys indicate that pup production in Oregon increased at 3 percent per year from 1990-2009, while pup production in California increased at 5 percent per year between 1996 and 2009, with the number of non-pups reported as stable. The best available information indicates that, overall, the eastern DPS has increased from an estimated 18,040 animals in 1979 to an estimated 63,488 animals in 2009; therefore the overall estimated rate of increase for this period is 4.3 percent per year (NMML, 2012).

In the far southern end of Steller sea lion range (Channel Islands in southern California), population declined significantly after the 1930s—probably due to hunting and harassment (Bartholomew and Boolootian, 1960; Bartholomew, 1967)—and several rookeries and haul-outs have been abandoned. The lack of recolonization at the southernmost portion of the range (e.g., San Miguel Island rookery), despite stability in the non-pup portion of the overall California population, is likely a response to a suite of factors, including changes in ocean conditions (e.g., warmer temperatures) that may be contributing to habitat changes that favor California sea lions over Steller sea lions (NMFS, 2007) and competition for space on land, and possibly prey, with species that have experienced explosive growth over the past three decades (California sea lions and northern elephant seals [Mirounga angustirostris]). Although recovery in California has lagged behind the rest of the DPS, this portion of the DPS' range has recently shown a positive growth rate (NMML, 2012). While non-pup counts in California in the 2000s are only 34 percent of pre-decline counts (1927-47), the population has increased significantly since 1990.

Despite the abandonment of certain rookeries in California, pup production at other rookeries in California has increased over the last 20 years and, overall, the eastern DPS has increased at an average annual growth rate of 4.3 percent per year for 30 years. Even though these rookeries might not be recolonized, their loss has not prevented the increasing abundance of Steller sea lions in California or in the eastern DPS overall.

Because the eastern DPS of Steller sea lion is currently listed as threatened under the ESA, it is therefore designated as depleted and classified as a strategic stock under the MMPA. However, the eastern DPS has been considered a potential candidate for removal from listing under the ESA by the Steller sea lion recovery team and NMFS (NMFS, 2008), based on observed annual rates of increase. Although the stock size has increased, the status of this stock relative to its Optimum Sustainable Population (OSP) size is unknown. The overall annual rate of increase of the eastern stock has been consistent and long-term, and may indicate that this stock is reaching OSP.

Behavior and Ecology—Steller sea lions forage near shore and in pelagic waters. They are capable of traveling long distances in a season and can dive to approximately 1,300 ft (400 m) in depth. They also use terrestrial habitat as haul-out sites for periods of rest, molting, and as rookeries for mating and pupping during the breeding season. At sea, they are often seen alone or in small groups, but may gather in large rafts at the surface near rookeries and haul-outs. Steller sea lions prefer the colder temperate to sub-arctic waters of the North Pacific Ocean. Haul-outs and rookeries usually consist of beaches (gravel, rocky or sand), ledges, and rocky reefs. In the Bering and Okhotsk Seas, sea lions may also haul-out on sea ice, but this is considered atypical behavior (NOAA, 2010a).

Steller sea lions are gregarious animals that often travel or haul out in large groups of up to 45 individuals (Keple, 2002). At sea, groups usually consist of female and subadult males; adult males are usually solitary while at sea (Loughlin, 2002). In the Pacific Northwest, breeding rookeries are located in British Columbia, Oregon, and northern California. Steller sea lions form large rookeries during late spring when adult males arrive and establish territories (Pitcher and Calkins, 1981). Large males aggressively defend territories while non-breeding males remain at peripheral sites or haul-outs. Females arrive soon after and give birth. Most births occur from mid-May through mid-July, and breeding takes place shortly thereafter. Most pups are weaned within a year. Non-breeding individuals may not return to rookeries during the breeding season but remain at other coastal haul-outs (Scordino, 2006).

Steller sea lions are opportunistic predators, feeding primarily on fish and cephalopods, and their diet varies geographically and seasonally (Bigg, 1985; Merricket al.,1997; Bredesenet al.,2006; Guenetteet al.,2006). Foraging habitat is primarily shallow, nearshore and continental shelf waters; freshwater rivers; and also deep waters (Reeveset al.,2008; Scordino, 2010). Steller sea lions occupy major winter haul-out sites on the coast of Vancouver Island in the Strait of Juan de Fuca and the Georgia Basin (Bigg, 1985; Olesiuk, 2008); the closest breeding rookery to the project area is at Carmanah Point near the western entrance to the Strait of Juan de Fuca. There are no known breeding rookeries in Washington (NMFS, 1992; Angliss and Outlaw, 2005) but Eastern stock Steller sea lions are present year-round along the outer coast of Washington at four major haul-out sites (NMFS, 2008a). Both sexes are present in Washington waters; these animals are likely immature or non-breeding adults from rookeries in other areas (NMFS, 2008a). In Washington, Steller sea lions primarily occur at haul-out sites along the outer coast from the Columbia River to Cape Flattery. In inland waters, Steller sea lions use haul-out sites along the Vancouver Island coastline of the Strait of Juan de Fuca (Jeffrieset al.,2000; COSEWIC, 2003; Olesiuk, 2008). Numbers vary seasonally in Washington waters with peak numbers present during the fall and winter months (Jeffrieset al.,2000). The highest breeding season Steller sea lion count at Washington haul-out sites was 847 individuals during the period from 1978 to 2001 (Pitcheret al.,2007). Non-breeding season surveys of Washington haul-out sites reported as many as 1,458 individuals between 1980 and 2001 (NMFS, 2008a).

Steller sea lions are occasionally present at the Toliva Shoals haul-out site in south Puget Sound (Jeffrieset al.,2000) and a rock three miles south of Marrowstone Island (NMFS, 2010). Fifteen Steller sea lions have been observed using this haul-out site. At NBKB, Steller sea lions have been observed hauled out on submarines at Delta Pier on several occasions from 2008 through 2011 during fall through spring months (October to April) (Navy 2010). Other potential haul-out sites may include isolated islands, rocky shorelines, jetties, buoys, rafts, and floats (Jeffrieset al.,2000). Steller sea lions likely utilize foraging habitats in Hood Canal similar to those of the California sea lion and harbor seal, which include marine nearshore and deeper water habitats.

Acoustics—Like all pinnipeds, the Steller sea lion is amphibious; while all foraging activity takes place in the water, breeding behavior is carried out on land in coastal rookeries (Mulsow and Reichmuth 2008). On land, territorial male Steller sea lions regularly use loud, relatively low-frequency calls/roars to establish breeding territories (Schustermanet al.,1970; Loughlinet al.,1987). The calls of females range from 0.03 to 3 kHz, with peak frequencies from 0.15 to 1 kHz; typical duration is 1.0 to 1.5 sec (Campbellet al.,2002). Pups also produce bleating sounds. Individually distinct vocalizations exchanged between mothers and pups are thought to be the main modality by which reunion occurs when mothers return to crowded rookeries following foraging at sea (Mulsow and Reichmuth, 2008).

Mulsow and Reichmuth (2008) measured the unmasked airborne hearing sensitivity of one male Steller sea lion. The range of best hearing sensitivity was between 5 and 14 kHz. Maximum sensitivity was found at 10 kHz, where the subject had a mean threshold of 7 dB. The underwater hearing threshold of a male Steller sea lion was significantly different from that of a female. The peak sensitivity range for the male was from 1 to 16 kHz, with maximum sensitivity (77 dB re: 1μPa-m) at 1 kHz. The range of best hearing for the female was from 16 to above 25 kHz, with maximum sensitivity (73 dB re: 1μPa-m) at 25 kHz. However, because of the small number of animals tested, the findings could not be attributed to either individual differences in sensitivity or sexual dimorphism (Kasteleinet al.,2005).

California Sea Lion

Species Description—California sea lions are members of the Otariid family (eared seals). The species,Zalophus californianus,includes three subspecies:Z. c. wollebaeki(in the Galapagos Islands),Z. c. japonicus(in Japan, but now thought to be extinct), andZ. c. californianus(found from southern Mexico to southwestern Canada; referred to here as the California sea lion) (Carrettaet al.,2007). The California sea lion is sexually dimorphic. Males may reach 1,000 lb (454 kg) and 8 ft (2.4 m) in length; females grow to 300 lb (136 kg) and 6 ft (1.8 m) in length. Their color ranges from chocolate brown in males to a lighter, golden brown in females. At around five years of age, males develop a bony bump on top of the skull called a sagittal crest. The crest is visible in the dog-like profile of male sea lion heads, and hair around the crest gets lighter with age.

Status—The U.S. stock of California sea lions is estimated at 238,000 and the minimum population size of this stock is 141,842 individuals (Carrettaet al.,2007). These numbers are from countsduring the 2001 breeding season of animals that were ashore at the four major rookeries in southern California and at haul-out sites north to the Oregon/California border. Sea lions that were at-sea or hauled-out at other locations were not counted (Carrettaet al.,2007). The stock has likely reached its carrying capacity and, even though current total human-caused mortality is unknown (due to a lack of observer coverage in the California set gillnet fishery that historically has been the largest source of human-caused mortalities), California sea lions are not considered a strategic stock under the MMPA because total human-caused mortality is still likely to be less than the potential biological removal (PBR). An estimated 3,000 to 5,000 California sea lions migrate to waters of Washington and British Columbia during the non-breeding season from September to May (Jeffrieset al.,2000). Peak numbers of up to 1,000 California sea lions occur in Puget Sound (including Hood Canal) during this time period (Jeffrieset al.,2000).

Distribution—The geographic distribution of California sea lions includes a breeding range from Baja California, Mexico to southern California. During the summer, California sea lions breed on islands from the Gulf of California to the Channel Islands and seldom travel more than about 31 mi (50 km) from the islands (Bonnellet al.,1983). The primary rookeries are located on the California Channel Islands of San Miguel, San Nicolas, Santa Barbara, and San Clemente (Le Boeuf and Bonnell, 1980; Bonnell and Dailey, 1993). Their distribution shifts to the northwest in fall and to the southeast during winter and spring, probably in response to changes in prey availability (Bonnell and Ford, 1987).

The non-breeding distribution extends from Baja California north to Alaska for males, and encompasses the waters of California and Baja California for females (Reeveset al.,2008; Maniscalcoet al.,2004). In the non-breeding season, an estimated 3,000-5,000 adult and sub-adult males migrate northward along the coast to central and northern California, Oregon, Washington, and Vancouver Island from September to May (Jeffrieset al.,2000) and return south the following spring (Mate, 1975; Bonnellet al.,1983). Along their migration, they are occasionally sighted hundreds of miles offshore (Jeffersonet al.,1993). Females and juveniles tend to stay closer to the rookeries (Bonnellet al.,1983).

California sea lions are present in Hood Canal during much of the year with the exception of mid-June through August, and occur regularly in the vicinity of the project site, as observed during Navy waterfront surveys conducted at NBKB from April 2008 through June 2010 (Navy, 2010). They are known to utilize man-made structures such as piers, jetties, offshore buoys, log booms, and oil platforms (Riedman, 1990), and are often seen rafted off of river mouths (Jeffrieset al.,2000). Although there are no regular California sea lion haul-outs known within the Hood Canal (Jeffrieset al.,2000), they are frequently observed hauled out at several opportune areas at NBKB (e.g., submarines, floating security fence, barges). As many as 58 California sea lions have been observed hauled out together at NBKB (Agness and Tannenbaum, 2009a; Tannenbaumet al.,2009a; Walters, 2009). California sea lions have also been observed swimming in the Hood Canal in the vicinity of the project area on several occasions and likely forage in both nearshore marine and inland marine deeper waters (DoN, 2001a).

Behavior and Ecology—California sea lions feed on a wide variety of prey, including many species of fish and squid (Everittet al.,1981; Roffe and Mate, 1984; Antoneliset al.,1990; Lowryet al.,1991). In the Puget Sound region, they feed primarily on fish such as Pacific hake (Merluccius productus), walleye pollock (Theragra chalcogramma), Pacific herring (Clupea pallasii), and spiny dogfish (Squalus acanthias) (Calambokidis and Baird, 1994). In some locations where salmon runs exist, California sea lions also feed on returning adult and out-migrating juvenile salmonids (London, 2006). Sexual maturity occurs at around four to five years of age for California sea lions (Heath, 2002). California sea lions are gregarious during the breeding season and social on land during other times.

Acoustics—On land, California sea lions make incessant, raucous barking sounds; these have most of their energy at less than 2 kHz (Schustermanet al.,1967). Males vary both the number and rhythm of their barks depending on the social context; the barks appear to control the movements and other behavior patterns of nearby conspecifics (Schusterman, 1977). Females produce barks, squeals, belches, and growls in the frequency range of 0.25-5 kHz, while pups make bleating sounds at 0.25-6 kHz. California sea lions produce two types of underwater sounds: clicks (or short-duration sound pulses) and barks (Schustermanet al.,1966, 1967; Schusterman and Baillet, 1969). All underwater sounds have most of their energy below 4 kHz (Schustermanet al.,1967).

The range of maximal hearing sensitivity underwater is between 1-28 kHz (Schustermanet al.,1972). Functional underwater high frequency hearing limits are between 35-40 kHz, with peak sensitivities from 15-30 kHz (Schustermanet al.,1972). The California sea lion shows relatively poor hearing at frequencies below 1 kHz (Kastak and Schusterman, 1998). Peak hearing sensitivities in air are shifted to lower frequencies; the effective upper hearing limit is approximately 36 kHz (Schusterman, 1974). The best range of sound detection is from 2-16 kHz (Schusterman, 1974). Kastak and Schusterman (2002) determined that hearing sensitivity generally worsens with depth—hearing thresholds were lower in shallow water, except at the highest frequency tested (35 kHz), where this trend was reversed. Octave band sound levels of 65-70 dB above the animal's threshold produced an average temporary threshold shift (TTS; discussed later in “Potential Effects of the Specified Activity on Marine Mammals”) of 4.9 dB in the California sea lion (Kastaket al.,1999).

Harbor Seal

Species Description—Harbor seals, which are members of the Phocid family (true seals), inhabit coastal and estuarine waters and shoreline areas from Baja California, Mexico to western Alaska. For management purposes, differences in mean pupping date (i.e., birthing) (Temte, 1986), movement patterns (Jeffries, 1985; Brown, 1988), pollutant loads (Calambokidiset al.,1985) and fishery interactions have led to the recognition of three separate harbor seal stocks along the west coast of the continental U.S. (Boveng, 1988). The three distinct stocks are: (1) Inland waters of Washington (including Hood Canal, Puget Sound, and the Strait of Juan de Fuca out to Cape Flattery), (2) outer coast of Oregon and Washington, and (3) California (Carrettaet al.,2007). The inland waters of Washington stock is the only stock that is expected to occur within the project area.

The average weight for adult seals is about 180 lb (82 kg) and males are slightly larger than females. Male harbor seals weigh up to 245 lb (111 kg) and measure approximately 5 ft (1.5 m) in length. The basic color of harbor seals' coat is gray and mottled but highly variable, from dark with light color rings or spots to light with dark markings (NMFS, 2008c).

Status—Estimated population numbers for the inland waters of Washington, including the Hood Canal,Puget Sound, and the Strait of Juan de Fuca out to Cape Flattery, are 14,612 individuals (Carrettaet al.,2007). The minimum population is 12,844 individuals. The harbor seal is the only species of marine mammal that is consistently abundant and considered resident in the Hood Canal (Jeffrieset al.,2003). The population of harbor seals in Hood Canal is a closed population, meaning that they do not have much movement outside of Hood Canal (London, 2006). The abundance of harbor seals in Hood canal has stabilized, and the population may have reached its carrying capacity in the mid-1990s with an approximate abundance of 1,000 harbor seals (Jeffrieset al.,2003).

Harbor seals are not considered to be depleted under the MMPA or listed under the ESA. Human-caused mortality relative to PBR is unknown, but it is considered to be small relative to the stock size. Therefore, the Washington Inland Waters stock of harbor seals is not classified as a strategic stock.

Harbor seals occur throughout Hood Canal and are seen relatively commonly in the area. They are year-round, non-migratory residents, and pup (i.e., give birth) in Hood Canal. Surveys in the Hood Canal from the mid-1970s to 2000 show a fairly stable population between 600-1,200 seals (Jeffrieset al.,2003). Harbor seals have been observed swimming in the waters along NBKB in every month of surveys conducted from 2007-2010 (Agness and Tannenbaum, 2009b; Tannenbaumet al.,2009b). On the NBKB waterfront, harbor seals have not been observed hauling out in the intertidal zone, but have been observed hauled-out on man-made structures such as the floating security fence, buoys, barges, marine vessels, and logs (Agness and Tannebaum, 2009a; Tannenbaumet al.,2009a). The main haul-out locations for harbor seals in Hood Canal are located on river delta and tidal exposed areas at Quilcene, Dosewallips, Duckabush, Hamma Hamma, and Skokomish River mouths (see Figure 4-1 of the Navy's application), with the closest haul-out area to the project area being ten miles (16 km) southwest of NBKB at Dosewallips River mouth, outside the potential area of effect for this project (London, 2006).

Behavior and Ecology—Harbor seals are typically seen in small groups resting on tidal reefs, boulders, mudflats, man-made structures, and sandbars. Harbor seals are opportunistic feeders that adjust their patterns to take advantage of locally and seasonally abundant prey (Payne and Selzer 1989; Baird 2001; Bjørge 2002). The harbor seal diet consists of fish and invertebrates (Bigg, 1981; Roffe and Mate, 1984; Orret al.,2004). Although harbor seals in the Pacific Northwest are common in inshore and estuarine waters, they primarily feed at sea (Orret al.,2004) during high tide. Researchers have found that they complete both shallow and deep dives during hunting depending on the availability of prey (Tollitet al.,1997). Their diet in Puget Sound consists of many of the prey resources that are present in the nearshore and deeper waters of NBKB, including hake, herring and adult and out-migrating juvenile salmonids. Harbor seals in Hood Canal are known to feed on returning adult salmon, including ESA-threatened summer-run chum (Oncorhynchus keta). Over a 5-year study of harbor seal predation in the Hood Canal, the average percent escapement of summer-run chum consumed was eight percent (London, 2006).

Harbor seals mate at sea and females give birth during the spring and summer, although the pupping season varies by latitude. In coastal and inland regions of Washington, pups are born from April through January. Pups are generally born earlier in the coastal areas and later in the Puget Sound/Hood Canal region (Calambokidis and Jeffries, 1991; Jeffrieset al.,2000). Suckling harbor seal pups spend as much as forty percent of their time in the water (Bowenet al.,1999).

Adult males also produce underwater sounds during the breeding season that typically range from 0.25-4 kHz (duration range: 0.1 s to multiple seconds; Hanggi and Schusterman 1994). Hanggi and Schusteman (1994) found that there is individual variation in the dominant frequency range of sounds between different males, and Van Parijset al.(2003) reported oceanic, regional, population, and site-specific variation that could be vocal dialects. In water, they hear frequencies from 1-75 kHz (Southallet al.,2007) and can detect sound levels as weak as 60-85 dB re 1 μPa within that band. They are most sensitive at frequencies below 50 kHz; above 60 kHz sensitivity rapidly decreases.

Humpback Whale

Species Description—The humpback whale is a baleen whale, and a member of the Balaenopterid family (rorquals), with a worldwide distribution in all ocean basins. Similar to all baleen whales, adult females are larger than adult males, reaching lengths of up to 60 ft (18 m). Their body coloration is primarily dark grey, but individuals have a variable amount of white on their pectoral fins and belly. This variation is so distinctive that the pigmentation pattern on the undersides of their flukes is used to identify individual whales. Humpback whales are known for their long pectoral fins, which can be up to 15 ft (4.6 m) in length and provide significant maneuverability. In the summer, most humpback whales are found in high latitude or highly biologically productive feeding grounds. In the winter, they congregate in subtropical or tropical waters for mating.

In the North Pacific, there are at least three separate populations: (1) CA/OR/WA stock, which winters in coastal Central America and Mexico and migrates to areas ranging from the coast of California to southern British Columbia in summer/fall; (2) Central North Pacific stock, which winters in the Hawaiian Islands and migrates to northern British Columbia/Southeast Alaska and Prince William Sound west to Kodiak; and (3) Western North Pacificstock, which winters near Japan and probably migrates to waters west of the Kodiak Archipelago (the Bering Sea and Aleutian Islands) in summer/fall. Though there is some mixing between these populations, they are considered distinct stocks. The stock structure of humpback whales is defined based on feeding areas, as distinct populations have a high degree of fidelity to specific feeding areas. Humpback whales found in inland Washington waters are members of the CA/OR/WA stock. Carrettaet al.(2011) described distinct feeding populations in the eastern Pacific, and the waters off northern Washington may be an area of mixing between the CA/OR/WA stock and British Columbia/Alaska whales, or whales in northern Washington and southern British Columbia may be a distinct feeding population and a separate stock.

Status—Humpback whales were listed as endangered under the Endangered Species Preservation Act of 1966 because of declines due to commercial whaling. This protection was transferred to the ESA in 1973. Because of this listing, it is therefore designated as depleted and classified as a strategic stock under the MMPA. The recovery plan for humpback whales was finalized in November 1991 (NMFS, 1991). Critical habitat has not been designated for this species.

Humpback whales are increasing in abundance through much of their range, including the CA/OR/WA stock. In the North Pacific, humpback abundance was estimated at fewer than 1,400 whales in 1966, after heavy commercial exploitation. The current abundance estimate for the North Pacific is about 20,000 whales in total. Carrettaet al.(2011) reported the best estimate for the CA/OR/WA stock as 2,043 individuals, based on mark-recapture estimates by Calambokidiset al.(2009). However, this estimate excludes some whales in Washington. Population trends from mark-recapture estimates have shown an overall long-term increase of approximately 7.5 percent per year for the CA/OR/WA stock (Calambokidis, 2009).

Distribution—The worldwide population of humpback whales is divided into various northern and southern ocean populations (Mackintosh, 1965). Geographical overlap of these populations has been documented only off Central America (Acevedo and Smultea, 1995; Rasmussenet al.,2004, 2007). The humpback whale is one of the most abundant cetaceans off the Pacific coast of Costa Rica during the winter breeding season of northern hemisphere humpbacks.

Humpback whales were one of the most common large cetaceans in the inland waters of Washington prior to the early 1900s (Scheffer and Slipp, 1948). However, sightings became infrequent in Puget Sound and the Georgia Basin through the late 1990s, and prior to 2003 the presence of only three individual humpback whales was confirmed (Falconeet al.,2005). However, in 2003 and 2004, thirteen individuals were sighted in the inland waters of Washington, mainly during the fall (Falconeet al.,2005). Records available for 2001 to 2012 include observations in the Strait of Juan de Fuca; the Gulf Islands and the vicinity of Victoria, British Columbia; Admiralty Inlet; the San Juan Islands; Hood Canal; and Puget Sound (Orca Network, 2012).

In Hood Canal, several humpback whale sightings were recorded beginning on January 27, 2012 (Orca Network, 2012). Review of the sightings information indicates the sightings are of a single individual. The most recent sighting reported was on February 17, 2012. It is currently unknown if this individual has left Hood Canal. Prior to these sightings, there have been no confirmed reports of humpback whales entering Hood Canal (Calambokidis, 2012). No other reports of humpback whales in the Hood Canal were found in the Orca Network database, the scientific literature, or agency reports. Construction of the Hood Canal Bridge occurred in 1961 and could have contributed to the lack of historical sightings (Calambokidis, 2010). Only a few records of humpback whales near Hood Canal are in the Orca Network database, but these are north of the Hood Canal Bridge.

Behavior and Ecology—Humpback whales travel great distances during their seasonal migrations from high latitude feeding grounds to tropical and subtropical breeding grounds. One of the more closely studied routes is between Alaska and Hawaii, where humpbacks have been observed making the 3,000 mi (4,830 km) trip in as few as 36 days. During the summer months, humpbacks spend the majority of their time feeding and building up fat reserves (blubber) that they will live off of during the winter breeding season. Humpbacks filter feed on tiny crustaceans (mostly krill), plankton, and small fish and are known to consume up to 3,000 lb (1,360 kg) of food per day. Several hunting methods involve using air bubbles to herd, corral, or disorient fish. One highly complex variant, called bubble netting, is unique to humpbacks and is often performed in groups with defined roles for distracting, scaring, and herding before whales lunge at prey corralled near the surface. While on their winter breeding grounds, humpback whales congregate and engage in mating activities. Humpbacks are generally polygynous, with males exhibiting competitive behavior including aggressive and antagonistic displays. Breeding usually occurs once every 2 years, but sometimes occurs twice in 3 years.

Although the humpback whale is considered a primarily coastal species, it often traverses deep pelagic areas while migrating (Clapham and Mattila, 1990; Norriset al.,1999; Calambokidiset al.,2001). During migration, humpbacks stay near the surface of the ocean, and tend to generally prefer shallow waters. During calving, humpbacks are usually found in the warmest waters available at that latitude. Calving grounds are commonly near offshore reef systems, islands, or continental shores. Humpback feeding grounds are in cold, productive coastal waters.

Humpback whales are often sighted singly or in groups of two or three, but while on breeding and feeding grounds they may occur in groups larger than twenty (Leatherwood and Reeves, 1983; Jeffersonet al.,2008). The diving behavior of humpback whales is related to time of year and whale activity (Clapham and Mead, 1999). In summer feeding areas, humpbacks typically forage in the upper 120 m of the water column, with a maximum recorded dive depth of 500 m (Dolphin, 1987; Dietzet al.,2002). On winter breeding grounds, humpback dives have been recorded at depths greater than 100 m (Bairdet al.,2000). The CA/OR/WA stock winters in coastal Central America and Mexico, and the stock migrates to areas ranging from the coast of California to southern British Columbia in summer and fall.

Acoustics—Humpback whales, like all baleen whales, are considered low-frequency cetaceans. Functional hearing for low-frequency cetaceans is estimated to range from 7 Hz to 22 kHz (Southallet al.,2007). During the winter breeding season, males sing complex songs that can last up to 20 minutes and be heard at great distance, and may sing for hours, repeating the song several times. All males in a population sing the same song, but that song continually evolves over time.

Killer Whale

Species Description—Killer whales are members of the Delphinid family and are the most widely distributed cetacean species in the world. Killer whales have a distinctive color pattern,with black dorsal and white ventral portions. They also have a conspicuous white patch above and behind the eye and a highly variable gray or white saddle area behind the dorsal fin. The species shows considerable sexual dimorphism. Adult males develop larger pectoral flippers, dorsal fins, tail flukes, and girths than females. Male adult killer whales can reach up to 32 ft (9.8 m) in length and weigh nearly 22,000 lb (10,000 kg); females reach 28 ft (8.5 m) in length and weigh up to 16,500 lb (7,500 kg).

Based on appearance, feeding habits, vocalizations, social structure, and distribution and movement patterns there are three types of populations of killer whales (Wiles, 2004; NMFS, 2005). The three distinct forms or types of killer whales recognized in the North Pacific Ocean are: (1) Resident, (2) Transient, and (3) Offshore. The resident and transient populations have been divided further into different subpopulations based mainly on genetic analyses and distribution; not enough is known about the offshore whales to divide them into subpopulations (Wiles, 2004). Only transient killer whales are known from the project area.

Transient killer whales occur throughout the eastern North Pacific, and have primarily been studied in coastal waters. Their geographical range overlaps that of the resident and offshore killer whales. The dorsal fin of transient whales tends to be more erect (straighter at the tip) than those of resident and offshore whales (Ford and Ellis, 1999; Fordet al.,2000). Saddle patch pigmentation of transient killer whales is restricted to two patterns, and never has the large areas of black pigmentation intruding into the white of the saddle patch that is seen in resident and offshore types. Transient type whales are often found in long-term stable social units that tend to be smaller than resident social groups (e.g., fewer than ten whales); these social units do not seem as permanent as matrilines are in resident type whales. Transient killer whales feed nearly exclusively on marine mammals (Ford and Ellis, 1999), whereas resident whales primarily eat fish. Offshore whales are presumed to feed primarily on fish, and have been documented feeding on sharks.

Within the transient type, association data (Fordet al.,1994; Ford and Ellis, 1999; Matkinet al.,1999), acoustic data (Saulitis, 1993; Ford and Ellis, 1999) and genetic data (Hoelzelet al.,1998, 2002; Barrett-Lennard, 2000) confirms that three communities of transient whales exist and represent three discrete populations: (1) Gulf of Alaska, Aleutian Islands, and Bering Sea transients, (2) AT1 transients (Prince William Sound, AK; listed as depleted under the MMPA), and (3) West Coast transients. Among the genetically distinct assemblages of transient killer whales in the northeastern Pacific, only the West Coast transient stock, which occurs from southern California to southeastern Alaska, may occur in the project area.

Status—The West Coast transient stock is a trans-boundary stock, with minimum counts for the population of transient killer whales coming from various photographic datasets. Combining these counts of cataloged transient whales gives a minimum number of 354 individuals for the West Coast transient stock (Allen and Angliss, 2010). However, the number in Washington waters at any one time is probably fewer than 20 individuals (Wiles, 2004). The West Coast transient killer whale stock is not designated as depleted under the MMPA or listed under the ESA. The estimated annual level of human-caused mortality and serious injury does not exceed the PBR. Therefore, the West Coast Transient stock of killer whales is not classified as a strategic stock. Population trends and status of this stock relative to its Optimum Sustainable Population (OSP) level are currently unknown.

Distribution—The geographical range of transient killer whales includes the northeast Pacific, with preference for coastal waters of southern Alaska and British Columbia (Krahnet al.,2002). Transient killer whales in the eastern North Pacific spend most of their time along the outer coast, but visit Hood Canal and the Puget Sound in search of harbor seals, sea lions, and other prey. Transient occurrence in inland waters appears to peak during August and September (Morton, 1990; Baird and Dill, 1995; Ford and Ellis, 1999) which is the peak time for harbor seal pupping, weaning, and post-weaning (Baird and Dill, 1995). In 2003 and 2005, small groups of transient killer whales (eleven and six individuals, respectively) visited Hood Canal to feed on harbor seals and remained in the area for significant periods of time (59 and 172 days, respectively) between the months of January and July.

Behavior and Ecology—Transient killer whales show greater variability in habitat use, with some groups spending most of their time foraging in shallow waters close to shore while others hunt almost entirely in open water (Fellemanet al.,1991; Baird and Dill, 1995; Matkin and Saulitis, 1997). Transient killer whales feed on marine mammals and some seabirds, but apparently no fish (Morton, 1990; Baird and Dill, 1996; Fordet al.,1998; Ford and Ellis, 1999; Fordet al.,2005). While present in Hood Canal in 2003 and 2005, transient killer whales preyed on harbor seals in the subtidal zone of the nearshore marine and inland marine deeper water habitats (London, 2006). Other observations of foraging transient killer whales indicate they prefer to forage on pinnipeds in shallow, protected waters (Heimlich-Boran, 1988; Saulitiset al.,2000). Transient killer whales travel in small, matrilineal groups, but they typically contain fewer than ten animals and their social organization generally is more flexible than that of resident killer whales (Morton, 1990, Ford and Ellis, 1999). These differences in social organization probably relate to differences in foraging (Baird and Whitehead, 2000). There is no information on the reproductive behavior of killer whales in this area.

Both behavioral and auditory brainstem response techniques indicate killer whales can hear in a frequency range of 1-100 kHz and are most sensitive at 20 kHz. This is one of the lowest maximum-sensitivity frequencies known among toothed whales (Szymanskiet al.,1999).

Dall's Porpoise

Species Description—Dall's porpoises are members of the Phocoenid (porpoise) family and are common in the North Pacific Ocean. They can reach a maximum length of just under 8 ft (2.4 m) and weigh up to 480 lb (218 kg). Males are slightly larger and thicker than females, which reach lengths of just under 7 ft (2.1 m) long. The body of Dall's porpoises is a very dark gray or black in coloration with variable contrasting white thoracic panels and white `frosting' on the dorsal fin and tail that distinguish them from other cetacean species. These markings and colorations vary with geographic region and life stage, with adults having more distinct patterns.

Based on NMFS stock assessment reports, Dall's porpoises within the Pacific U.S. Exclusive Economic Zone are divided into two discrete, noncontiguous areas: (1) Waters off California, Oregon, and Washington, and (2) Alaskan waters (Carrettaet al.,2008). Only individuals from the CA/OR/WA stock may occur within the project area.

Status—The NMFS population estimate, recently updated in 2010 for the CA/OR/WA stock, is 42,000 (CV = 0.33) which is based on vessel line transect surveys by Barlow (2010) and Forney (2007). The minimum population is considered to be 32,106. Additional numbers of Dall's porpoises occur in the inland waters of Washington, but the most recent estimate was obtained in 1996 (900 animals; CV = 0.40; Calambokidiset al.,1997) and is not included in the overall estimate of abundance for this stock due to the need for more up-to-date information. Dall's porpoise are not listed as depleted under the MMPA or listed under the ESA. The average annual human-caused mortality is estimated to be less than the PBR, and therefore the stock is not classified as a strategic stock under the MMPA. The status of Dall's porpoises in California, Oregon and Washington relative to OSP is not known, and there are insufficient data to evaluate potential trends in abundance.

Distribution—The Dall's porpoise is found from northern Baja California, Mexico, north to the northern Bering Sea and south to southern Japan (Jeffersonet al.,1993). The species is only common between 32-62° N in the eastern North Pacific (Morejohn, 1979; Houck and Jefferson, 1999). North-south movements in California, Oregon, and Washington have been suggested. Dall's porpoises shift their distribution southward during cooler-water periods (Forney and Barlow, 1998). Norris and Prescott (1961) reported finding Dall's porpoises in southern California waters only in the winter, generally when the water temperature was less than 15°C (59 °F). Seasonal movements have also been noted off Oregon and Washington, where higher densities of Dall's porpoises were sighted offshore in winter and spring and inshore in summer and fall (Greenet al.,1992).

In Washington, they are most abundant in offshore waters. They are year-round residents in Washington (Greenet al.,1992), but their distribution is highly variable between years, likely due to changes in oceanographic conditions (Forney and Barlow, 1998). Dall's porpoises are observed throughout the year in the Puget Sound north of Seattle (Osborneet al.,1998) and are seen occasionally in southern Puget Sound. Dall's porpoises may also occasionally occur in Hood Canal (Jeffries 2006, personal communication). Nearshore habitats used by Dall's porpoises could include the marine habitats found in the inland marine waters of the Hood Canal. A Dall's porpoise was observed in the deeper water at NBKB in summer 2008 (Tannenbaumet al.,2009a).

Behavior and Ecology—Dall's porpoises can be opportunistic feeders but primarily consume schooling forage fish. They are known to eat squid, crustaceans, and fishes such as blackbelly eelpout (Lycodopsis pacifica), herring, pollock, hake, and Pacific sandlance (Ammodytes hexapterus) (Walkeret al.,1998). Groups of Dall's porpoises generally include fewer than ten individuals and are fluid, probably aggregating for feeding (Jefferson, 1990, 1991; Houck and Jefferson, 1999). Dall's porpoises become sexually mature at three and a half to eight years of age (Houck and Jefferson, 1999) and give birth to a single calf after ten to twelve months. Breeding and calving typically occurs in the spring and summer (Angell and Balcomb, 1982). In the North Pacific, there is a strong summer calving peak from early June through August (Ferrero and Walker, 1999), and a smaller peak in March (Jefferson, 1989). Resident Dall's porpoises breed in Puget Sound from August to September.

Acoustics—Only short duration pulsed sounds have been recorded for Dall's porpoises (Houck and Jefferson, 1999); this species apparently does not whistle often (Richardsonet al.,1995). Dall's porpoises produce short duration (50-1,500 μs), high-frequency, narrow band clicks, with peak energies between 120-160 kHz (Jefferson, 1988). There is no published data on the hearing abilities of this species.

Harbor Porpoise

Species Description—Harbor porpoises belong to the Phocoenid (porpoise) family and are found extensively along the Pacific U.S. coast. Harbor porpoises are small, with males reaching average lengths of approximately 5 ft (1.5 m); Females are slightly larger with an average length of 5.5 ft (1.7 m). The average adult harbor porpoise weighs between 135-170 lb (61-77 kg). Harbor porpoises have a dark grey coloration on their backs, with their belly and throats white. They have a dark grey chin patch and intermediate shades of grey along their sides.

Recent preliminary genetic analyses of samples ranging from Monterey, CA to Vancouver Island, BC indicate that there is small-scale subdivision within the U.S. portion of this range (Chiverset al.,2002). Although geographic structure exists along an almost continuous distribution of harbor porpoises from California to Alaska, stock boundaries are difficult to draw because any rigid line is generally arbitrary from a biological perspective. Nevertheless, based on genetic data and density discontinuities identified from aerial surveys, NMFS identifies eight stocks in the Northeast Pacific Ocean. Pacific coast harbor porpoise stocks include: (1) Monterey Bay, (2) San Francisco-Russian River, (3) northern California/southern Oregon, (4) Oregon/Washington coastal, (5) inland Washington, (6) Southeast Alaska, (7) Gulf of Alaska, and (8) Bering Sea. Only individuals from the Washington Inland Waters stock may occur in the project area.

Status—Aerial surveys of the inland waters of Washington and southern British Columbia were conducted during August of 2002 and 2003 (J. Laake, unpubl. data). These aerial surveys included the Strait of Juan de Fuca, San Juan Islands, Gulf Islands, and Strait of Georgia, which includes waters inhabited by the Washington Inland Waters stock of harbor porpoises as well as harbor porpoises from British Columbia. An average of the 2002 and 2003 estimates of abundance in U.S. waters resulted in an uncorrected abundance of 3,123 (CV = 0.10) harbor porpoises in Washington inland waters (J. Laake, unpubl. data). When corrected for availability and perception bias, the estimated abundance for the Washington Inland Waters stock of harbor porpoise is 10,682 (CV = 0.38) animals (Carrettaetal.,2008). The minimum population estimate is 7,841. Harbor porpoise are not listed as depleted under the MMPA or listed under the ESA. Based on currently available data, the total level of human-caused mortality is not known to exceed the PBR. Therefore, the Washington Inland Waters harbor porpoise stock is not classified as strategic. The status of this stock relative to its OSP level and population trends is unknown. Although long-term harbor porpoise sightings in southern Puget Sound have declined since the 1940s, sightings have increased in Puget Sound and northern Hood Canal in recent years and are now considered to regularly occur year-round in these waters (Calambokidis, 2010). This may represent a return to historical conditions, when harbor porpoises were considered one of themost common cetaceans in Puget Sound (Scheffer and Slipp, 1948).

Distribution—Harbor porpoises are generally found in cool temperate to subarctic waters over the continental shelf in both the North Atlantic and North Pacific (Read, 1999). This species is seldom found in waters warmer than 17 °C (63 °F; Read, 1999) or south of Point Conception (Hubbs, 1960; Barlow and Hanan, 1995). Harbor porpoises can be found year-round primarily in the shallow coastal waters of harbors, bays, and river mouths (Greenet al.,1992). Along the Pacific coast, harbor porpoises occur from Monterey Bay, California to the Aleutian Islands and west to Japan (Reeveset al.,2002). Harbor porpoises are known to occur in Puget Sound year round (Osmeket al.,1996, 1998; Carrettaet al.,2007), and harbor porpoise observations in northern Hood Canal have increased in recent years (Calambokidis, 2010). Prior to recent construction projects conducted by the Navy at NBKB, harbor porpoises were considered as likely occurring only occasionally in the project area. A single harbor porpoise had been sighted in deeper water at NBKB during 2010 field observations (SAIC, 2010). However, while implementing monitoring plans for work conducted from July-October, 2011, the Navy recorded multiple sightings of harbor porpoise in the deeper waters of the project area. Following these sightings, the Navy conducted dedicated line transect surveys, recording multiple additional sightings of harbor porpoise, and have revised local density estimates accordingly. The current density estimates are based upon a small sample size of transect surveys, and may be further revised as more information becomes available from ongoing Navy survey efforts.

Behavior and Ecology—Harbor porpoises are non-social animals usually seen in small groups of two to five animals. Little is known about their social behavior. Harbor porpoises can be opportunistic foragers but primarily consume schooling forage fish (Osmeket al.,1996; Bowen and Siniff, 1999; Reeveset al.,2002). Along the coast of Washington, harbor porpoises primarily feed on herring, market squid (Loligo opalescens) and eulachon (Thaleichthys pacificus) (Gearinet al.,1994). Females reach sexual maturity at three to four years of age and may give birth every year for several years in a row. Calves are born in late spring (Read, 1990; Read and Hohn, 1995). Dall's and harbor porpoises appear to hybridize relatively frequently in the Puget Sound area (Williset al.,2004).

Acoustics—Harbor porpoise vocalizations include clicks and pulses (Ketten, 1998), as well as whistle-like signals (Verboom and Kastelein, 1995). The dominant frequency range is 110-150 kHz, with source levels of 135-177 dB re 1 μPa-m (Ketten, 1998). Echolocation signals include one or two low-frequency components in the 1.4-2.5 kHz range (Verboom and Kastelein, 1995).

A behavioral audiogram of a harbor porpoise indicated the range of best sensitivity is 8-32 kHz at levels between 45-50 dB re 1 μPa-m (Andersen, 1970); however, auditory-evoked potential studies showed a much higher frequency of approximately 125-130 kHz (Bibikov, 1992). The auditory-evoked potential method suggests that the harbor porpoise actually has two frequency ranges of best sensitivity. More recent psycho-acoustic studies found the range of best hearing to be 16-140 kHz, with a reduced sensitivity around 64 kHz (Kasteleinet al.,2002). Maximum sensitivity occurs between 100-140 kHz (Kasteleinet al.,2002).

Potential Effects of the Specified Activity on Marine Mammals

NMFS has determined that pile removal, as outlined in the project description, has the potential to result in behavioral harassment of marine mammals that may be swimming, foraging, or resting in the project vicinity while pile removal is being conducted. Pile removal could potentially harass those pinnipeds that are in the water close to the project site, whether their heads are above or below the surface.

Marine Mammal Hearing

The primary effect on marine mammals anticipated from the specified activities would result from exposure of animals to underwater sound. Exposure to sound can affect marine mammal hearing. When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data, Southallet al.(2007) designate functional hearing groups for marine mammals and estimate the lower and upper frequencies of functional hearing of the groups. The functional groups and the associated frequencies are indicated below (though animals are less sensitive to sounds at the outer edge of their functional range and most sensitive to sounds of frequencies within a smaller range somewhere in the middle of their functional hearing range):

• Low frequency cetaceans (13 species of mysticetes): functional hearing is estimated to occur between approximately 7 Hz and 22 kHz;

• Mid-frequency cetaceans (32 species of dolphins, six species of larger toothed whales, and nineteen species of beaked and bottlenose whales): Functional hearing is estimated to occur between approximately 150 Hz and 160 kHz;

• High frequency cetaceans (six species of true porpoises, four species of river dolphins, two members of the genusKogia,and four dolphin species of the genusCephalorhynchus): Functional hearing is estimated to occur between approximately 200 Hz and 180 kHz; and

• Pinnipeds in water: Functional hearing is estimated to occur between approximately 75 Hz and 75 kHz, with the greatest sensitivity between approximately 700 Hz and 20 kHz.

As mentioned previously in this document, three pinniped and four cetacean species are likely to occur in the proposed project area. Of the four cetacean species likely to occur in the project area, two are classified as high frequency cetaceans (Dall's and harbor porpoises), one is classified as a mid-frequency cetacean (killer whales), and one is classified as a low-frequency cetacean (humpback whales) (Southallet al.,2007).

Underwater Sound Effects

Potential Effects of Construction Sound—The effects of sounds from pile removal might—in theory, at least—result in one or more of the following: Temporary or permanent hearing impairment, non-auditory physical or physiological effects, behavioral disturbance, and masking (Richardsonet al.,1995; Gordonet al.,2004; Nowaceket al.,2007; Southallet al.,2007). The effects of pile driving or removal on marine mammals are generally dependent on several factors, including the size, type, and depth of the animal; the depth, intensity, and duration of the pile removal sound; the depth of the water column; the substrate of the habitat; the standoff distance between the pile and the animal; and the sound propagation properties of the environment. Impacts to marine mammals from the proposed activities are expected to result primarily from acoustic pathways. As such, the degree of effect is intrinsically related to the received level and duration of the sound exposure, which are in turn influenced by the distance between the animal andthe source. The further away from the source, the less intense the exposure should be. The substrate and depth of the habitat affect the sound propagation properties of the environment. Shallow environments are typically more structurally complex, which leads to rapid sound attenuation. In addition, substrates that are soft (e.g., sand) would absorb or attenuate the sound more readily than hard substrates (e.g., rock) which may reflect the acoustic wave. Soft porous substrates would also likely require less time to remove the pile, which would ultimately decrease the intensity of the acoustic source.

In the absence of mitigation, impacts to marine species would be expected to result from physiological and behavioral responses to both the type and strength of the acoustic signature (Viadaet al.,2008). The type and severity of behavioral impacts are more difficult to define due to limited studies addressing the behavioral effects of underwater sounds on marine mammals. Potential effects from sound sources can range in severity, ranging from effects such as behavioral disturbance, tactile perception, physical discomfort, slight injury of the internal organs and the auditory system, to mortality (Yelvertonet al.,1973; O'Keefe and Young, 1984; DoN, 2001b).

Hearing Impairment and Other Physical Effects—Marine mammals exposed to high intensity sound repeatedly or for prolonged periods can experience hearing threshold shift (TS), which is the loss of hearing sensitivity at certain frequency ranges (Kastaket al.,1999; Schlundtet al.,2000; Finneranet al.,2002, 2005). TS can be permanent (PTS), in which case the loss of hearing sensitivity is not recoverable, or temporary (TTS), in which case the animal's hearing threshold would recover over time (Southallet al.,2007). Marine mammals depend on acoustic cues for vital biological functions, (e.g., orientation, communication, finding prey, avoiding predators); thus, TTS may result in reduced fitness in survival and reproduction, either permanently or temporarily. However, this depends on the frequency and duration of TTS, as well as the biological context in which it occurs. TTS of limited duration, occurring in a frequency range that does not coincide with that used for recognition of important acoustic cues, would have little to no effect on an animal's fitness. Repeated sound exposure that leads to TTS could cause PTS. PTS is considered to constitute injury, but TTS is not considered injury (Southallet al.,2007). It is unlikely that the project would result in any cases of temporary or especially permanent hearing impairment or any significant non-auditory physical or physiological effects; these effects are most frequently associated with pulsed sound, which would not occur during the proposed action. Some behavioral disturbance is expected, but it is likely that this would be localized and short-term because of the short project duration.

In addition, given the low source levels expected in association with the non-pulsed sounds proposed for this activity, it is highly unlikely that any marine mammals could experience physiological effects or even TTS. All source levels for the proposed action would be less than 190 dB re: 1 μPa rms; therefore, there is no possibility of injury for pinnipeds. While vibratory pile removal is expected to produce sound equaling the 180 dB threshold for potential cetacean injury, that sound is expected to be restricted to a radius no more than 1 m (3.3 ft) from the pile removal, therefore essentially eliminating the possibility for cetacean injury, as it is extremely unlikely that any cetacean would approach so closely. Nevertheless, several aspects of the planned monitoring and mitigation measures for this project (see the “Proposed Mitigation” and “Proposed Monitoring and Reporting” sections later in this document) are designed to detect marine mammals occurring near the pile removal to avoid exposing them to sound that might, in theory, cause injury. The following subsection discusses TTS in somewhat more detail.

Temporary Threshold Shift—TTS is the mildest form of hearing impairment that can occur during exposure to a strong sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises, and a sound must be stronger in order to be heard. In terrestrial mammals, TTS can last from minutes or hours to days (in cases of strong TTS). For sound exposures at or somewhat above the TTS threshold, hearing sensitivity in both terrestrial and marine mammals recovers rapidly after exposure to the sound ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals. Available data on TTS in marine mammals are summarized in Southallet al.(2007).

Disturbance Reactions

Disturbance includes a variety of effects, including subtle changes in behavior, more conspicuous changes in activities, and displacement. Reactions to sound, if any, depend on species, state of maturity, experience, current activity, reproductive state, time of day, and many other factors (Richardsonet al.,1995; Wartzoket al.,2004; Southallet al.,2007; Weilgart, 2007). Behavioral responses to sound are highly variable and context specific. For each potential behavioral change, the magnitude of the change ultimately determines the severity of the response. A number of factors may influence an animal's response to sound, including its previous experience, its auditory sensitivity, its biological and social status (including age and sex), and its behavioral state and activity at the time of exposure.

Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzoket al.,2003/04). Animals are most likely to habituate to sounds that are predictable and unvarying. The opposite process is sensitization, when an unpleasant experience leads to subsequent responses, often in the form of avoidance, at a lower level of exposure. Behavioral state may affect the type of response as well. For example, animals that are resting may show greater behavioral change in response to disturbing sound levels than animals that are highly motivated to remain in an area for feeding (Richardsonet al.,1995; NRC, 2003; Wartzoket al.,2003/04). Controlled experiments with captive marine mammals showed pronounced behavioral reactions, including avoidance of loud sound sources (Ridgwayet al.,1997; Finneranet al.,2003). However, responses to non-pulsed sound, such as vibratory pile installation, have not been documented as well as responses to pulsed sounds.

With both types of pile removal, it is likely that the onset of pile removal could result in temporary, short term changes in an animal's typical behavior and/or avoidance of the affected area. These behavioral changes may include (Richardsonet al.,1995): Changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where sound sources are located; and/or flight responses (e.g., pinnipeds flushing into water from haul-outs or rookeries). Pinnipeds may increase their haul-out time, possibly to avoid in-water disturbance (Caltrans 2001, 2006). Since pile removal would likely only occur for a few hours a day, over a short period of time, it is unlikely to result in permanent displacement. Any potential impacts from pile removal activitiescould be experienced by individual marine mammals, but would not be likely to cause population level impacts, or affect the long-term fitness of the species.

The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be expected to be biologically significant if the change affects growth, survival, or reproduction. Significant behavioral modifications that could potentially lead to effects on growth, survival, or reproduction include:

• Drastic changes in diving/surfacing patterns (such as those thought to be causing beaked whale stranding due to exposure to military mid-frequency tactical sonar);

• Habitat abandonment due to loss of desirable acoustic environment; and

• Cessation of feeding or social interaction.

The onset of behavioral disturbance from anthropogenic sound depends on both external factors (characteristics of sound sources and their paths) and the specific characteristics of the receiving animals (hearing, motivation, experience, demography) and is difficult to predict (Southallet al.,2007).

Auditory Masking

Natural and artificial sounds can disrupt behavior by masking, or interfering with, a marine mammal's ability to hear other sounds. Masking occurs when the receipt of a sound is interfered with by another coincident sound at similar frequencies and at similar or higher levels. Chronic exposure to excessive, though not high-intensity, sound could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions. Masking can interfere with detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. Therefore, under certain circumstances, marine mammals whose acoustical sensors or environment are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction. If the coincident (masking) sound were man-made, it could be potentially harassing if it disrupted hearing-related behavior. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.

The frequency range of the potentially masking sound is important in determining any potential behavioral impacts. Because sound generated from in-water pile removal is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds made by porpoises. However, lower frequency man-made sounds are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey sound. It may also affect communication signals when they occur near the sound band and thus reduce the communication space of animals (e.g., Clarket al.,2009) and cause increased stress levels (e.g., Footeet al.,2004; Holtet al.,2009).

Masking has the potential to impact species at population, community, or even ecosystem levels, as well as at individual levels. Masking affects both senders and receivers of the signals and can potentially have long-term chronic effects on marine mammal species and populations. Recent research suggests that low frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, and that most of these increases are from distant shipping (Hildebrand, 2009). All anthropogenic sound sources, such as those from vessel traffic, pile removal, and dredging activities, contribute to the elevated ambient sound levels, thus intensifying masking. However, the sum of sound from the proposed activities is confined in an area of inland waters (Hood Canal) that is bounded by landmass; therefore, the sound generated is not expected to contribute to increased ocean ambient sound.

Typically, the most intense underwater sounds associated with marine construction are those produced by impact pile removal, which is not proposed for this action. However, the energy distribution of pile removal covers a broad frequency spectrum, and sound from these sources would likely be within the audible range of the marine mammals found in the Hood Canal. Vibratory pile removal is relatively short-term, with rapid oscillations occurring for approximately 1 hour per pile, with the total vibratory pile removal occurring for 15 days. The probability for vibratory pile removal masking acoustic signals important to the behavior and survival of marine mammal species is likely to be negligible. Any masking event that could possibly rise to Level B harassment under the MMPA would occur concurrently within the zones of behavioral harassment already estimated for pile removal, and which have already been taken into account in the exposure analysis.

Airborne Sound Effects

Marine mammals that occur in the project area could be exposed to airborne sounds associated with pile removal that have the potential to cause harassment, depending on their distance from pile removal activities. Airborne pile removal sound would have less impact on cetaceans than pinnipeds because sound from atmospheric sources does not transmit well underwater (Richardsonet al.,1995); thus, airborne sound would only be an issue for pinnipeds that are hauled-out or have their heads above water in the project area. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon their habitat and move further from the source. Studies by Blackwellet al.(2004) and Moultonet al.(2005) indicate a tolerance or lack of response to unweighted airborne sounds as high as 96 dB rms.

Anticipated Effects on Habitat

The proposed activities at NBKB would not result in permanent impacts to habitats used directly by marine mammals, such as haul-out sites, but may have potential short-term impacts to food sources such as forage fish and salmonids. There are no rookeries or major haul-out sites within 10 km (6.2 mi), foraging hotspots, or other ocean bottom structures of significant biological importance to marine mammals that may be present in the marine waters in the vicinity of the project area. Therefore, the main impact issue associated with the proposed activity would be temporarily elevated sound levels and the associated direct effects on marine mammals, as discussed previously in this document. The most likely impact to marine mammal habitat occurs from pile removal effects on likely marine mammal prey (i.e., fish) near NBKB and minor impacts to the immediate substrate during removal of piles during the wharf rehabilitation project.

Pile Removal Effects on Potential Prey (Fish)

Construction activities would produce non-pulsed sounds. Fish react to sounds which are especially strong and/or intermittent low-frequency sounds which are generally unlike the sounds that would be produced by the proposed action. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. Hastings and Popper (2005, 2009) identified several studies that suggest fish may relocate to avoid certain areas of sound energy. SPLs of 180 dB may cause noticeable changes in behavior (Chapman and Hawkins, 1969; Pearsonet al.,1992; Skalskiet al.,1992). SPLs of sufficient strength have been known to cause injury to fish and fish mortality (Caltrans, 2001; Longmuir and Lively, 2001). The most likely impact to fish from pile removal activities at the project area would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile removal stops is unknown, but a rapid return to normal recruitment, distribution and behavior is anticipated. In general, impacts to marine mammal prey species are expected to be minor and temporary due to the short timeframe and nature of sound produced for the project. Impacts could also result from potential impacts to fish eggs and larvae.

Pile Removal Effects on Potential Foraging Habitat

The area likely impacted by the project is relatively small compared to the available habitat in the Hood Canal. Avoidance by potential prey (i.e., fish) of the immediate area due to the temporary loss of this foraging habitat is also possible. The duration of fish avoidance of this area after pile removal stops is unknown, but a rapid return to normal recruitment, distribution and behavior is anticipated. Any behavioral avoidance by fish of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the Hood Canal and nearby vicinity.

Given the short daily duration of sound associated with individual pile removal events and the relatively small areas being affected, pile removal activities associated with the proposed action are not likely to have a permanent, adverse effect on any fish habitat, or populations of fish species. Therefore, pile removal is not likely to have a permanent, adverse effect on marine mammal foraging habitat at the project area.

Previous Activity

The proposed action for this IHA request represents the second year of a 2-year project. NMFS issued an IHA for the first year of work on May 24, 2011 (76 FR 30130). The Navy complied with the mitigation and monitoring required under the previous authorization. In accordance with the 2011 IHA, the Navy submitted a monitoring report, and the information contained therein was considered in this analysis. During the course of activities conducted under the previous authorization, the Navy did not exceed the take levels authorized under that IHA. Additional information regarding harbor porpoise, Steller sea lion, and humpback whale occurrence in the Hood Canal has been considered in this analysis.

Proposed Mitigation

In order to issue an incidental take authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must, where applicable, set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

The modeling results for zones of influence (ZOIs; see “Estimated Take by Incidental Harassment”) were used to develop mitigation measures for pile removal activities at NBKB. ZOIs are often used to effectively represent the mitigation zone that would be established around each pile to prevent Level A harassment of marine mammals, and also establish zones within which Level B harassment of marine mammals may occur. In addition to the measures described later in this section, the Navy would employ the following standard mitigation measures:

(a) Conduct briefings between construction supervisors and crews, marine mammal monitoring team, acoustical monitoring team, and Navy staff prior to the start of all pile removal activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

(b) Comply with applicable equipment sound standards and ensure that all construction equipment has sound control devices no less effective than those provided on the original equipment.

(c) For in-water heavy machinery work other than pile removal, if a marine mammal comes within 10 m (33 ft), operations shall cease and vessels shall reduce speed to the minimum level required to maintain steerage and safe working conditions. This type of work could include, for example, movement of the barge to the pile location or removal of the pile from the water column/substrate via a crane (i.e., direct pull). For these activities, monitoring would take place from 15 minutes prior to initiation until the action is complete.

Monitoring and Shutdown

The following measures would apply to the Navy's mitigation through shutdown and disturbance zones:

Shutdown Zone—For all pile removal activities, the Navy would establish a shutdown zone (defined as, at minimum, the area in which SPLs equal or exceed the 180/190 dB rms acoustic injury criteria). The purpose of a shutdown zone is to define an area within which shutdown of activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area), thus preventing injury, serious injury, or death of marine mammals. Although predictions indicate that radial distances to the 180/190-dB threshold would be less than 10 m—or would not exist because source levels are lower than the threshold—shutdown zones would conservatively be set at a minimum 10 m. This precautionary measure is intended to further reduce any possibility of injury to marine mammals by incorporating a buffer to the 180/190-dB threshold within the shutdown area.

Disturbance Zone—For all pile removal activities, the Navy would establish a disturbance zone. Disturbance zones are typically defined as the area in which SPLs equal or exceed 120 dB rms (for non-pulsed sound). However, when the size of a disturbance zone is sufficiently large as to make monitoring of the entire area impracticable (as in the case of the vibratory removal zone here, predicted to encompass an area of 35.9 km2), the disturbance zone may be defined as some area that may reasonably be monitored. The Navy would establish an observation position within the Waterfront Restricted Area (WRA), maximally distant from the pile removal operations. The additional position would be able to monitor an effective area of at least 542 m distance (corresponding to the predicted radial distance to the 120-dB threshold for chipping) from the pile removal activity. In addition, the Navy would place a protected species observer (PSO) aboardany vessel used outside the WRA for hydroacoustic monitoring, for the duration of any such monitoring. Disturbance zones provide utility for monitoring conducted for mitigation purposes (i.e., shutdown zone monitoring) by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring of disturbance zones enables PSOs to be aware of and communicate the presence of marine mammals in the project area but outside the shutdown zone and thus prepare for potential shutdowns of activity. However, the primary purpose of disturbance zone monitoring is for documenting incidents of Level B harassment; disturbance zone monitoring is discussed in greater detail later (see Proposed Monitoring and Reporting). As with any such large action area, it is impossible to guarantee that all animals would be observed or to make comprehensive observations of fine-scale behavioral reactions to sound.

All disturbance and shutdown zones would initially be based on the distances from the source that are predicted for each threshold level. However, should data from previously conducted acoustic monitoring (i.e., from monitoring of test pile or previous EHW-1 work), which is still in preparation, or from in-situ acoustic monitoring indicate that actual distances to these threshold zones are different, the size of the shutdown and disturbance zones would be adjusted accordingly.

Monitoring Protocols—Monitoring would be conducted for a minimum 10 m shutdown zone and a minimum approximate 600 m disturbance zone (although this may be larger for the duration of hydroacoustic monitoring) surrounding each pile for the presence of marine mammals before, during, and after pile removal activities. If a marine mammal is observed within the disturbance zone, a take would be recorded and behaviors documented. However, that pile segment would be completed without cessation, unless the animal approaches or enters the shutdown zone, at which point all pile removal activities would be halted.

The disturbance zone was set at the largest area practicable for the Navy to maintain a monitoring presence over the duration of the activity. Sightings occurring outside this area (within the predicted 35.9 km2disturbance zone predicted for the vibratory removal 120-dB isopleths) would still be recorded and noted as a take, but detailed observations outside this zone would not be possible, and it would be impossible for the Navy to account for all individuals occurring in such a zone with any degree of certainty. Monitoring would take place from 15 minutes prior to initiation through 30 minutes post-completion of pile removal activities. Pile removal activities include the time to remove a single pile or series of piles, as long as the time elapsed between uses of the pile removal equipment is no more than 30 minutes.

The following additional measures would apply to visual monitoring:

(a) Monitoring would be conducted by qualified observers. Qualified observers are trained biologists, with the following minimum qualifications:

• Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;

• Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);

• Experience or training in the field identification of marine mammals, including the identification of behaviors;

• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and

• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

A trained observer would be placed from the best vantage point(s) practicable (e.g., from a small boat, the pile removal barge, on shore, or any other suitable location) to monitor for marine mammals and implement shutdown or delay procedures when applicable by calling for the shutdown to the equipment operator.

(b) Prior to the start of pile removal activity, the shutdown zone would be monitored for 15 minutes to ensure that it is clear of marine mammals. Pile removal would only commence once observers have declared the shutdown zone clear of marine mammals; animals would be allowed to remain in the disturbance zone (i.e., must leave of their own volition) and their behavior would be monitored and documented.

(c) If a marine mammal approaches or enters the shutdown zone during the course of pile removal operations, pile removal would be halted and delayed until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed without re-detection of the animal.

Acoustic Measurements

Acoustic measurements would be used to empirically verify the predicted shutdown and disturbance zones for pneumatic chipping. For further detail regarding the Navy's acoustic monitoring plan see “Proposed Monitoring and Reporting”.

Timing Restrictions

The Navy has set timing restrictions for pile removal activities to avoid in-water work when ESA-listed fish populations are most likely to be present. The in-water work window for avoiding negative impacts to fish species is July 16-February 15.

Soft Start

The use of a soft-start procedure is believed to provide additional protection to marine mammals by warning, or providing marine mammals a chance to leave the area prior to the hammer operating at full capacity. The wharf rehabilitation project would utilize soft-start techniques for vibratory pile removal. The soft-start requires contractors to initiate sound from vibratory hammers for fifteen seconds at reduced energy followed by a 30-second waiting period. This procedure would be repeated two additional times.

Daylight Construction

Pile removal and other in-water work would occur only during daylight hours (i.e., civil dawn to civil dusk).

Mitigation Effectiveness

It should be recognized that although marine mammals would be protected through the use of measures described here, the efficacy of visual detection depends on several factors including the observer's ability to detect the animal, the environmental conditions (visibility and sea state), and monitoring platforms. All observers utilized for mitigation activities would be experienced biologists with training in marine mammal detection and behavior.Trained observers have specific knowledge of marine mammal physiology, behavior, and life history, which may improve their ability to detect individuals or help determine if observed animals are exhibiting behavioral reactions to construction activities.

The Puget Sound region, including the Hood Canal, only infrequently experiences winds with velocities in excess of 25 kn (Morriset al.,2008). The typically light winds afforded by the surrounding highlands coupled with the fetch-limited environment of the Hood Canal result in relatively calm wind and sea conditions throughout most of the year. The wharf rehabilitation project site has a maximum fetch of 8.4 mi (13.5 km) to the north, and 4.2 mi (6.8 km) to the south, resulting in maximum wave heights of from 2.85-5.1 ft (0.9-1.6 m) (Beaufort Sea State (BSS) between two and four), even in extreme conditions (30 kt winds) (CERC, 1984). Visual detection conditions are considered optimal in BSS conditions of three or less, which align with the conditions that should be expected for the wharf rehabilitation project at NBKB.

NMFS has carefully evaluated the applicant's proposed mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals; (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation, including consideration of personnel safety, and practicality of implementation.

Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

Proposed Monitoring and Reporting

In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must, where applicable, set forth “requirements pertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that would result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

Acoustic Monitoring

The Navy would conduct acoustic monitoring for pneumatic chipping of concrete piles to determine the actual distances to the 120 dB re 1 μPa rms isopleths for behavioral harassment relative to background levels. Underwater sound levels were measured at the project site in 2011 in the absence of construction activities to determine background sound levels and, therefore, will not be recorded again during this work window. Airborne acoustic monitoring would be conducted during pile removal through chipping to identify the actual distance to the 90 dB re 20 μPa rms and 100 dB re 20 μPa rms airborne isopleths.

At a minimum, the methodology would include:

• Acoustic monitoring will be conducted on a minimum of five concrete piles.

• For underwater recordings, a stationary hydrophone system with the ability to measure SPLs will be placed in accordance with NMFS' most recent guidance for collection of source levels.

• For airborne recordings, reference recordings will be attempted at approximately 50 ft (15.2 meters) from the source via a stationary hydrophone. However, other distances may be utilized to obtain better data if the signal cannot be isolated clearly due to other sound sources (i.e., barges or generators).

• Each hydrophone (underwater) and microphone (airborne) will be calibrated prior to the start of the action and will be checked at the beginning of each day of monitoring activity. Other hydrophones will be placed at other distances and/or depths as necessary to determine the distance to the thresholds for marine mammals.

• Environmental data will be collected including but not limited to: Wind speed and direction, wave height, water depth, precipitation, and type and location of in-water construction activities, as well as other factors that could contribute to influencing the airborne and underwater sound levels (e.g. aircraft, boats);

• The construction contractor will supply the Navy and other relevant monitoring personnel with the substrate composition, hammer model and size, hammer energy settings and any changes to those settings during the piles being monitored.

• For acoustically monitored piles, post-analysis of the sound level signals will include the average, minimum, and maximum rms value for each pile monitored during removal. A frequency spectrum will also be provided for the pneumatic chipping signal.

• Airborne levels would be recorded as an unweighted time series. The distance to marine mammal airborne sound disturbance thresholds would be determined.

Visual Monitoring

The Navy would collect sighting data and behavioral responses to construction for marine mammal species observed in the region of activity during the period of activity. All observers would be trained in marine mammal identification and behaviors. NMFS requires that the observers have no other construction-related tasks while conducting monitoring.

Methods of Monitoring—The Navy would monitor the shutdown zone and disturbance zone before, during, and after pile removal. There would, at all times, be at least one observer stationed at an appropriate vantage point to observe the shutdown zones associated with each operating hammer. There would also at all times be at least one vessel-based observer stationed within the WRA. In addition, at least one marine mammal observer would be stationed on any vessel conducting acoustic monitoring outside the WRA, for as long as such monitoring is conducted. Based on NMFS requirements, the Marine Mammal Monitoring Plan would include the following procedures for pile removal:

(1) MMOs would be located at the best vantage point(s) in order to properly see the entire shutdown zone and as much of the disturbance zone as possible. This may require the use of a small boat to monitor certain areas while also monitoring from one or more land based vantage points.

(2) During all observation periods, observers would use binoculars and the naked eye to search continuously for marine mammals.

(3) If the shutdown or disturbance zones are obscured by fog or poor lighting conditions, pile removal at that location would not be initiated until that zone is visible.

(4) The shutdown and disturbance zones around the pile would bemonitored for the presence of marine mammals before, during, and after any pile removal activity.

Pre-Activity Monitoring—The shutdown and disturbance zones would be monitored for 15 minutes prior to initiating pile removal. If marine mammal(s) are present within the shutdown zone prior to pile removal, or during the soft start, the start of pile removal would be delayed until the animal(s) leave the shutdown zone. Pile removal would resume only after the PSO has determined, through observation or by waiting 15 minutes, that the animal(s) has moved outside the shutdown zone.

During Activity Monitoring—The shutdown and disturbance zones would also be monitored throughout the time required to remove a pile. If a marine mammal is observed entering the disturbance zone, a take would be recorded and behaviors documented. However, that pile segment would be completed without cessation, unless the animal enters or approaches the shutdown zone, at which point all pile removal activities would be halted. Pile removal can only resume once the animal has left the shutdown zone of its own volition or has not been resighted for a period of 15 minutes.

Post-Activity Monitoring—Monitoring of the shutdown and disturbance zones would continue for 30 minutes following the completion of pile removal.

Individuals implementing the monitoring protocol would assess its effectiveness using an adaptive approach. Monitoring biologists would use their best professional judgment throughout implementation and would seek improvements to these methods when deemed appropriate. Any modifications to protocol would be coordinated between the Navy and NMFS.

Data Collection

NMFS requires that the PSOs use NMFS-approved sighting forms. In addition to the following requirements, the Navy would note in their behavioral observations whether an animal remains in the project area following a Level B taking (which would not require cessation of activity). This information would ideally make it possible to determine whether individuals are taken (within the same day) by one or more types of pile removal. NMFS requires that, at a minimum, the following information be collected on the sighting forms:

(5) Species, numbers, and, if possible, sex and age class of marine mammals;

(6) Marine mammal behavior patterns observed, including bearing and direction of travel, and if possible, the correlation to SPLs;

(7) Distance from pile removal activities to marine mammals and distance from the marine mammals to the observation point;

(8) Locations of all marine mammal observations; and

(9) Other human activity in the area.

Reporting

A draft acoustic monitoring report would be submitted to NMFS within 90 calendar days of the completion of the acoustic measurements. Separately, a draft marine mammal monitoring report would be submitted within 90 calendar days of the completion of construction activity. The report would include marine mammal observations pre-activity, during-activity, and post-activity during pile removal days. Final reports would be prepared and submitted to NMFS within 30 days following receipt of comments on the draft report from NMFS. At a minimum, the reports would include:

• The vibratory hammer force or chipping hammer setting used to extract the piles;

• A description of the monitoring equipment;

• The distance between hydrophone(s) and pile;

• The depth of the hydrophone(s);

• The physical characteristics of the bottom substrate from which the pile was extracted (if possible);

• The rms range and mean for each monitored pile;

• The results of the acoustic measurements, including the frequency spectrum, peak and rms SPLs for each monitored pile;

• The results of the airborne sound measurements (unweighted levels);

• Date and time observation is initiated and terminated;

• A description of any observable marine mammal behavior in the immediate area and, if possible, the correlation to underwater sound levels occurring at that time;

• Actions performed to minimize impacts to marine mammals;

• Times when pile removal is stopped due to presence of marine mammals within shutdown zones and time when pile removal resumes;

• Results, including the detectability of marine mammals, species and numbers observed, sighting rates and distances, behavioral reactions within and outside of shutdown zones; and

• A refined take estimate based on the number of marine mammals observed in the shutdown and disturbance zones.

Estimated Take by Incidental Harassment

With respect to the activities described here, the MMPA defines “harassment” as: “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

All anticipated takes would be by Level B harassment, involving temporary changes in behavior. The proposed mitigation and monitoring measures are expected to minimize the possibility of injurious or lethal takes such that take by Level A harassment, serious injury or mortality is considered remote. However, it is unlikely that injurious or lethal takes would occur even in the absence of the planned mitigation and monitoring measures.

If a marine mammal responds to an underwater sound by changing its behavior (e.g., through relatively minor changes in locomotion direction/speed or vocalization behavior), the response may or may not constitute taking at the individual level, and is unlikely to affect the stock or the species as a whole. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on animals or on the stock or species could potentially be significant (Lusseau and Bejder, 2007; Weilgart, 2007). Given the many uncertainties in predicting the quantity and types of impacts of sound on marine mammals, it is common practice to estimate how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound. This practice potentially overestimates the numbers of marine mammals taken. For example, during the past 10 years, killerwhales have been observed within the project area twice. On the basis of that information, an estimated amount of potential takes for killer whales is presented here. However, while a pod of killer whales could potentially visit again during the project timeframe, and thus be taken, it is more likely that they would not.

The proposed project area is not believed to be particularly important habitat for marine mammals, although harbor seals are year-round residents of Hood Canal and sea lions are known to haul-out on submarines and other man-made objects at the NBKB waterfront (although typically at a distance of a mile or greater from the project site). Therefore, behavioral disturbances that could result from anthropogenic sound associated with the proposed activities are expected to affect only a relatively small number of individual marine mammals, although those effects could be recurring if the same individuals remain in the project vicinity.

The Navy is requesting authorization for the potential taking of small numbers of Steller sea lions, California sea lions, harbor seals, transient killer whales, Dall's porpoises, and harbor porpoises in the Hood Canal that may result from pile removal during construction activities associated with the wharf rehabilitation project described previously in this document. No incidental take of humpback whale is predicted. The takes requested are expected to have no more than a minor effect on individual animals and no effect at the population level for these species. Any effects experienced by individual marine mammals are anticipated to be limited to short-term disturbance of normal behavior or temporary displacement of animals near the source of the sound.

Marine Mammal Densities

For all species, the best scientific information available was used to construct density estimates or estimate local abundance. Of available information deemed suitable for use, the data that produced the most conservative (i.e., highest) density or abundance estimate for each species was used. For harbor seals, this involved published literature describing harbor seal research conducted in Washington and Oregon as well as more specific counts conducted in Hood Canal (Huberet al.,2001; Jeffrieset al.,2003). Killer whales are known from two periods of occurrence (2003 and 2005) and are not known to preferentially use any specific portion of the Hood Canal. Therefore, density was calculated as the maximum number of individuals present at a given time during those occurrences (London, 2006), divided by the area of Hood Canal. The best information available for the remaining species in Hood Canal came from surveys conducted by the Navy at the NBKB waterfront or in the vicinity of the project area. These consist of three discrete sets of survey effort, and are described here in greater detail.

Beginning in April 2008, Navy personnel have recorded sightings of marine mammals occurring at known haul-outs along the NBKB waterfront, including docked submarines or other structures associated with NBKB docks and piers and the nearshore pontoons of the floating security fence. Sightings of marine mammals within the waters adjoining these locations were also recorded. Sightings were attempted whenever possible during a typical work week (i.e., Monday through Friday), but inclement weather, holidays, or security constraints often precluded surveys. These sightings took place frequently (average fourteen per month) although without a formal survey protocol. During the surveys, staff visited each of the above-mentioned locations and recorded observations of marine mammals. Surveys were conducted using binoculars and the naked eye from shoreline locations or the piers/wharves themselves. Because these surveys consist of opportunistic sighting data from shore-based observers, largely of hauled-out animals, there is no associated survey area appropriate for use in calculating a density from the abundance data. Thus, NMFS has not used these data to derive a density but rather has used the absolute abundance to estimate take. For analysis in this proposed IHA, data were compiled for the period from April 2008 through June 2010—with the additional inclusion of twelve surveys from October 2011 in which only Steller sea lion observations were recorded, as this was the first record of Steller sea lion presence during the month of October—and these data provided the basis for take estimation for Steller and California sea lions. Other information, including sightings data from other Navy survey efforts at NBKB, is available for these two species, but these data provide the most conservative (i.e., highest) local abundance estimates (and thus the highest estimates of potential take). For all other species, the data source that provided the most conservative density estimate was used.

Vessel-based marine wildlife surveys were conducted according to established survey protocols during July through September 2008 and November through May 2009-10 (Tannenbaumet al.,2009, 2011). Eighteen complete surveys of the nearshore area resulted in observations of four marine mammal species (harbor seal, California sea lion, harbor porpoise, and Dall's porpoise). These surveys operated along pre-determined transects parallel to the shoreline from the nearshore out to approximately 1,800 ft (549 m) from shoreline, at a spacing of 100 yd (91 m), and covered the entire NBKB waterfront (approximately 3.9 km2per survey) at a speed of 5 kn or less. Two observers recorded sightings of marine mammals both in the water and hauled out, including date, time, species, number of individuals, age (juvenile, adult), behavior (swimming, diving, hauled out, avoidance dive), and haul-out location. Positions of marine mammals were obtained by recording distance and bearing to the animal with a rangefinder and compass, noting the concurrent location of the boat with GPS, and, subsequently, analyzing these data to produce coordinates of the locations of all animals detected. These surveys produced the information used to estimate take for Dall's porpoise.

During 2011 construction activities, marine mammal monitoring was conducted on construction days for mitigation purposes. During those efforts, the Navy observed that harbor porpoises were more common in deeper waters of Hood Canal than the previously described, nearshore vessel-based surveys indicated. For that reason, the Navy conducted vessel-based line transect surveys in Hood Canal on days when no construction activities occurred in order to collect additional density data for species present in Hood Canal. These surveys were primarily conducted in September and detected three marine mammal species (harbor seal, California sea lion, and harbor porpoise), and included surveys conducted in both the main body of Hood Canal, near the project area, and baseline surveys conducted for comparison in Dabob Bay, an area of Hood Canal that is not affected by sound from Navy actions at the NBKB waterfront (see Figures 2-1 and 4-1 in the Navy's application). The surveys operated along pre-determined transects that followed a double saw-tooth pattern to achieve uniform coverage of the entire NBKB waterfront. The vessel traveled at a speed of approximately 5 kn when transiting along the transect lines. Two observers recorded sightings of marine mammals both in the water and hauled out, including the date, time, species, number of individuals,and behavior (swimming, diving, etc.). Positions of marine mammals were obtained by recording the distance and bearing to the animal(s), noting the concurrent location of the boat with GPS, and subsequently analyzing these data to produce coordinates of the locations of all animals detected. Sighting information for harbor porpoises was corrected for detectability (g(0) = 0.54; Barlow, 1988; Calambokidiset al.,1993; Carrettaet al.,2001). Distance sampling methodologies were used to estimate densities of animals for these data. Due to the recent execution of these surveys, not all data have been processed. Due to the unexpected abundance of harbor porpoises encountered, data for this species were processed first and are available for use in this proposed IHA. All other species data may be included in subsequent environmental compliance documents once all post-processing is complete, but preliminary analysis indicates that use of the previously described data would still provide the most conservative take estimates for the other species.

The cetaceans, as well as the harbor seal, appear to range throughout Hood Canal; therefore, the analysis in this proposed IHA assumes that harbor seal, humpback whale, transient killer whale, harbor porpoise, and Dall's porpoise are uniformly distributed in the project area. However, it should be noted that there have been no observations of cetaceans within the WRA security barrier; the barrier thus appears to effectively prevent cetaceans from approaching the shutdown zones (please see Figure 6-2 of the Navy's application; the WRA security barrier, which is not denoted in the figure legend, is represented by a thin gray line). Although source levels associated with the proposed actions are so low that no Level A harassments would likely occur even in the absence of any mitigation measures, it appears that cetaceans at least are not at risk of Level A harassment at NBKB even from louder activities (e.g., impact pile driving). The remaining species that occur in the project area, Steller sea lion and California sea lion, do not appear to utilize most of Hood Canal. The sea lions appear to be attracted to the man-made haul-out opportunities along the NBKB waterfront while dispersing for foraging opportunities elsewhere in Hood Canal. California sea lions were not reported during aerial surveys of Hood Canal (Jeffrieset al.,2000), and Steller sea lions have only been documented at the NBKB waterfront.

Description of Take Calculation

The take calculations presented here rely on the best data currently available for marine mammal populations in the Hood Canal, as discussed in preceding sections. The formula was developed for calculating take due to pile removal activity and applied to each group-specific sound impact threshold. The formula is founded on the following assumptions:

• All pilings to be installed would have a sound disturbance distance equal to that of the piling that causes the greatest sound disturbance (i.e., the piling furthest from shore);

• All marine mammal individuals potentially available are assumed to be present within the relevant area, and thus incidentally taken; and,

• An individual can only be taken once during a 24-hour period.

The calculation for marine mammal takes is estimated by:

Take estimate = (n * ZOI) * days of total activity

Where:n = density estimate used for each species/seasonZOI = sound threshold zone of influence (ZOI) impact area; the area encompassed by all locations where the SPLs equal or exceed the threshold being evaluatedn * ZOI produces an estimate of the abundance of animals that could be present in the area for exposure, and is rounded to the nearest whole number before multiplying by days of total activity.

The ZOI impact area is the estimated range of impact to the sound criteria. The distances specified in Tables 2 and 4 (actual distances rather than modeled) were used to calculate ZOI around each pile. The ZOI impact area took into consideration the possible affected area of the Hood Canal from the pile removal site furthest from shore with attenuation due to land shadowing from bends in the canal. Because of the close proximity of some of the piles to the shore, the narrowness of the canal at the project area, and the maximum fetch, the ZOIs for each threshold are not necessarily spherical and may be truncated.

For sea lions, as described previously, the surveys offering the most conservative estimates of abundance do not have a defined survey area and so are not suitable for deriving a density construct. Instead, abundance is estimated on the basis of previously described opportunistic sighting information at the NBKB waterfront, and it is assumed that the total amount of animals known from NBKB haul-outs would be “available” to be taken in a given pile removal day. Thus, for these two species, take is estimated by multiplying abundance by days of activity.

The total number of days spent removing piles is expected to be a maximum of 15 for vibratory removal and 32 for chipping. While pile removal can occur any day throughout the in-water work window, and the analysis is conducted on a per day basis, only a fraction of that time is actually spent in pile removal. For each pile, vibratory pile removal is expected to be no more than 1 hour. Pneumatic chipping is expected to take approximately 2 hours per pile.

The exposure assessment methodology is an estimate of the numbers of individuals exposed to the effects of pile removal activities exceeding NMFS-established thresholds. Of note in these exposure estimates, mitigation methods (i.e., visual monitoring and the use of shutdown zones) were not quantified within the assessment and successful implementation of this mitigation is not reflected in exposure estimates. Results from acoustic impact exposure assessments should be regarded as conservative estimates.

Airborne Sound—No incidents of incidental take are predicted as a result of exposure to airborne sound, using the formula given in this section and the information from Table 4. This is primarily due to the low source levels associated with the specified activities. However, it is NMFS' view that authorization for incidental take resulting from exposure to airborne sound, in the absence of any haul-outs or opportunities for an animal to haul out within the ZOI, would effectively result in double counting. Such exposure results when pinnipeds raise their heads above water; thus, those individuals are within the larger ZOI corresponding to Level B harassment resulting from underwater sound produced by the same source, and are already exposed and considered as an incidental take. As noted previously, NMFS considers an individual as able to be incidentally taken once per 24-hour period. Multiple incidents of exposure to sound above NMFS' thresholds for behavioral harassment are not believed to result in increased behavioral disturbance, in either nature or intensity of disturbance reaction.

California Sea Lion

California sea lions are present in Hood Canal during much of the year with the exception of mid-June through August. California sea lions occur regularly in the vicinity of the projectsite from September through mid-June, as determined by Navy waterfront surveys conducted from April 2008 through June 2010 (Navy, 2010; Table 6). With regard to the range of this species in Hood Canal and the project area, it is assumed on the basis of waterfront observations (Agness and Tannenbaum, 2009; Tannenbaumet al.,2009, 2011) that the opportunity to haul out on submarines docked at Delta Pier is a primary attractant for California sea lions in Hood Canal, as they have rarely been reported, either hauled out or swimming, elsewhere in Hood Canal (Jeffries, 2007). Abundance is calculated as the monthly average of the maximum number observed in a given month, as opposed to the overall average (Table 6). For example, in the month of May, the maximum number of animals observed on any one day was 25 in 2008, 33 in 2009, and 17 in 2010, providing a monthly average of the maximum daily number observed of 25. This provides a conservative overall daily abundance of 26.2 for the in-water work window, as compared with an actual per survey abundance of 11.4 during the same period.

Frequency of presence1Abundance2January25150.6024.0February28240.8631.0March28260.9338.5April38270.7136.3May44340.7725.0June4470.165.3July31000August2910.030.5September2690.3522.0October26220.8545.5November2222154.0December24140.5832.5Total or average (in-water work season only)2111070.5326.2Totals (number of surveys) and averages (frequency and abundance) presented for in-water work season (July-February) only. Information from March-June presented for reference.1Frequency is the number of surveys with California sea lions present/number of surveys conducted.2Abundance is calculated as the monthly average of the maximum daily number observed in a given month.

The largest observed number of California sea lions hauled out along the NBKB waterfront was 58 in a November survey. During the in-water construction period (mid-July to mid-February) the largest daily attendance average for each month ranged from 24 individuals to 54 individuals. The likelihood of California sea lions being present at NBKB is greatest from October through May, when the frequency of attendance in surveys was at least 0.58. Attendance along the NBKB waterfront in November surveys (2008-09) was 100 percent. Additionally, five navigational buoys near the entrance to Hood Canal were documented as potential haul-outs, each capable of supporting three adult California sea lions (Jeffrieset al.,2000). Breeding rookeries are in California; therefore, pups are not expected to be present in Hood Canal (NMFS 2008b). Female California sea lions are rarely observed north of the California/Oregon border; therefore, only adult and sub-adult males are expected to be exposed to project impacts.

The ZOI for vibratory removal encompasses areas where California sea lions are known to haul-out; assuming that 26 individuals could be taken per day of vibratory removal provides an estimate of 390 takes for that activity. The ZOI for pneumatic chipping does not encompass areas where California sea lions are known to occur; nevertheless, it is likely that some individuals would transit this area in route to haul out or forage. Therefore, and in order to ensure that the Navy is adequately authorized for incidental take, NMFS predicts that at least one individual California sea lion could be exposed to sound levels indicating Level B harassment per day of pneumatic chipping. Table 8 depicts the estimated number of behavioral harassments.

Steller Sea Lion

Steller sea lions were first documented at the NBKB waterfront in November 2008, while hauled out on submarines at Delta Pier (Bhuthimethee, 2008; Navy, 2010) and have been periodically observed since that time. Steller sea lions typically occur at NBKB from November through April; however, the first October sightings of Steller sea lions at NBKB occurred in 2011. Based on waterfront observations, Steller sea lions appear to use available haul-outs (typically in the vicinity of Delta Pier, approximately one mile south of the project area) and habitat similarly to California sea lions, although in lesser numbers. On occasions when Steller sea lions are observed, they typically occur in mixed groups with California sea lions also present, allowing observers to confirm their identifications based on discrepancies in size and other physical characteristics. During October 2011, up to four individuals were sighted either hauled out at the submarines docked at Delta Pier or swimming in the waters just adjacent to those haul-outs.

Vessel-based survey effort in NBKB nearshore waters have not detected any Steller sea lions (Agness and Tannenbaum, 2009; Tannenbaumet al.,2009, 2011). Opportunistic sightings data provided by Navy personnel since April 2008 have continued to document sightings of Steller sea lions at Delta Pier from November through April (Table 7). Steller sea lions have only been observed hauled out on submarines docked at Delta Pier. Delta Pier and other docks at NBKB are not accessible to pinnipeds due to the height above water, although the smaller California sea lions and harbor seals are able to haul out on pontoons that support the floating security barrier. One to two animals are typically seen hauled out with California sea lions; the maximum Steller sea lion group size seen at any given time was six individuals in November 2009.

Frequency of presence1Abundance2January2540.161.0February2810.040.5March2840.141.0April3850.131.3May44000June44000July31000August29000September26000October38120.321.3November2230.145.0December2450.211.5Total or average

(in-water work season only)

223250.111.2Totals (number of surveys) and averages (frequency and abundance) presented for in-water work season (July-February) only. Information from March-June presented for reference.1Frequency is the number of surveys with Steller sea lions present/number of surveys conducted.2Abundance is calculated as the monthly average of the maximum daily number observed in a given month.

Their frequency of occurrence by month typically has not exceeded 0.21 (in December 2009), i.e., they were present in only 21 percent of surveys that month. However, all 12 surveys conducted in October 2011 resulted in Steller sea lion sightings, raising the frequency of occurrence for that month to 0.32. The time period from November through April coincides with the time when Steller sea lions are frequently observed in Puget Sound. Only adult and sub-adult males are likely to be present in the project area during this time; female Steller sea lions have not been observed in the project area. Since there are no known breeding rookeries in the vicinity of the project site, Steller sea lion pups are not expected to be present. By May, most Steller sea lions have left inland waters and returned to their rookeries to mate. Although sub-adult individuals (immature or pre-breeding animals) will occasionally remain in Puget Sound over the summer, observational data (Table 7) have indicated that Steller sea lions are present only from October through April and not during the summer months.

Local abundance information, rather than density, was used in estimating take for Steller sea lions. Please see the discussion provided previously for California sea lions. Steller sea lions are known only from haul-outs over one mile from the project area, and would not be subject to harassment from airborne sound. The ZOI for vibratory removal encompasses areas where Steller sea lions are known to haul-out; assuming that one individual could be taken per day of vibratory removal provides an estimate of fifteen takes for that activity. However, the available abundance information does not reflect the nature of Steller sea lion occurrence at NBKB. According to the most recent observational information, if Steller sea lions are present at NBKB, it is possible that as many as four individuals could be present on submarines docked at Delta Pier or in waters adjacent to these haul-outs. Thus, NMFS conservatively assumes that up to four individuals could be exposed to sound levels indicating Level B harassment per day of vibratory pile removal. Similar to California sea lions, the ZOI for pneumatic chipping does not encompass areas where Steller sea lions are known to occur; nevertheless, it is possible that some individuals could transit this area in route to haul out or forage. Therefore, and in order to ensure that the Navy is adequately authorized for incidental take, NMFS predicts that at least one individual Steller sea lion could be exposed to sound levels indicating Level B harassment per day of pneumatic chipping. Table 8 depicts the number of estimated behavioral harassments.

Harbor Seal

Harbor seals are the most abundant marine mammal in Hood Canal, where they can occur anywhere in Hood Canal waters year-round. The Navy detected harbor seals during marine mammal boat surveys of the waterfront area from July to September 2008 (Tannenbaumet al.,2009) and November to May 2010 (Tannenbaumet al.,2011), as described previously. Harbor seals were sighted during every survey and were found in all marine habitats including nearshore waters and deeper water, and hauled out on certain manmade objects, such as the pontoons of the floating security barrier. During most of the year, all age and sex classes could occur in the project area throughout the period of construction activity. As there are no known regular pupping sites in the vicinity of the project area, harbor seal neonates are not expected to be present during pile removal. However, the first documented birth of a harbor seal at NBKB occurred in August 2011 at Carderock Pier (several miles south of the project site), so the presence of neonates is possible, if unlikely. Otherwise, during most of the year, all age and sex classes could occur in the project area throughout the period of construction activity. Harbor seal numbers increase from January through April and then decrease from May through August as the harbor seals move to adjacent bays on the outer coast of Washington for the pupping season. From April through mid-July, female harbor seals haul out on the outer coast of Washington at pupping sites to give birth. The main haul-out locations for harbor seals in Hood Canal are located on river delta and tidal exposed areas at various river mouths, with the closest haul-out area to the project area being 10 mi (16 km) southwest of NBKB (London, 2006). Please see Figure 4-1 of the Navy's application for a map of haul-out locations in relation to the project area.

Jeffrieset al.(2003) conducted aerial surveys of the harbor seal population in Hood Canal in 1999 for the Washington Department of Fish and Wildlife and reported 711 harbor seals hauled out. The authors adjusted this abundance with a correction factor of 1.53 to account for seals in the water, whichwere not counted, and estimated that there were 1,088 harbor seals in Hood Canal. The correction factor (1.53) was based on the proportion of time seals spend on land versus in the water over the course of a day, and was derived by dividing one by the percentage of time harbor seals spent on land. These data came from tags (VHF transmitters) applied to harbor seals at six areas (Grays Harbor, Tillamook Bay, Umpqua River, Gertrude Island, Protection/Smith Islands, and Boundary Bay, BC) within two different harbor seal stocks (the coastal stock and the inland waters of WA stock) over four survey years. The Hood Canal population is part of the inland waters stock, and while not specifically sampled, Jeffrieset al.(2003) found the VHF data to be broadly applicable to the entire stock. The tagging research in 1991 and 1992 conducted by Huberet al.(2001) and Jeffrieset al.(2003) used the same methods for the 1999 and 2000 survey years. These surveys indicated that approximately 35 percent of harbor seals are in the water versus hauled out on a daily basis (Huberet al.,2001; Jeffrieset al.,2003). Exposures were calculated using a density derived from the number of harbor seals that are present in the water at any one time (35 percent of 1,088, or approximately 381 individuals), divided by the area of the Hood Canal (291 km2[112 mi2]) and the formula presented previously.

NMFS recognizes that over the course of the day, while the proportion of animals in the water may not vary significantly, different individuals may enter and exit the water. However, fine-scale data on harbor seal movements within the project area on time durations of less than a day are not available. Previous monitoring experience from Navy actions conducted from July-October 2011 in the same project area has indicated that this density provides an appropriate estimate of potential exposures. Data from those monitoring efforts are currently in post-processing and are not available in report form at this time. However, the density of harbor seals calculated in this manner (1.3 animals/km2) is corroborated by results of the Navy's vessel-based marine mammal surveys at NBKB in 2008 and 2009-10, in which an average of five individual harbor seals per survey was observed in the 3.9 km2survey area (density = 1.3 animals/km2) (Tannenbaumet al.,2009, 2011). Table 8 depicts the number of estimated behavioral harassments.

Humpback Whales

One humpback whale has recently been documented in Hood Canal. This individual was originally sighted on January 27, 2012 and, while potentially still present, was last reported on February 23, 2012. Although known to be historically abundant in the inland waters of Washington, no other confirmed documentation of humpback whales in Hood Canal is available. Their presence has likely not occurred in several decades, with the last known reports being anecdotal accounts of three humpback sightings from 1972-82. Although it cannot be confirmed that this individual has departed the Hood Canal, with the absence of sighting records since February 23 (following regular sightings between January 27-February 23) and the lack of any historical regular occurrence in the Hood Canal it is likely that this individual has departed and that no humpback whales would be present in the proposed action area. In addition, the proposed action is estimated to occur for only 15 days, with short pile removal durations per day. As described before, cetaceans are not known from within the WRA and it's virtually impossible that an animal as large as a humpback whale could occur within the WRA; therefore, sound from pneumatic chipping, which is not expected to extend beyond the floating security barrier, would not have the potential to affect humpback whales. NMFS believes that the possibility for incidental take of humpback whales is discountable. In addition to the preceding rationale given in support of this belief, a density was derived from the available information: One humpback whale ranging through the Hood Canal (291 km2), or 0.003 animals/km2. Using this density and the formula given previously, no takes are predicted.

Killer Whales

Transient killer whales are uncommon visitors to Hood Canal. Transients may be present in the Hood Canal anytime during the year and traverse as far as the project site. Resident killer whales have not been observed in Hood Canal, but transient pods (six to eleven individuals per event) were observed in Hood Canal for lengthy periods of time (59-172 days) in 2003 (January-March) and 2005 (February-June), feeding on harbor seals (London, 2006).

These whales used the entire expanse of Hood Canal for feeding. Subsequent aerial surveys suggest that there has not been a sharp decline in the local seal population from these sustained feeding events (London, 2006). Based on this data, the density for transient killer whales in the Hood Canal for January to June is 0.038/km2(eleven individuals divided by the area of the Hood Canal [291 km2]). Table 8 depicts the number of estimated behavioral harassments.

Dall's Porpoise

Dall's porpoises may be present in the Hood Canal year-round and could occur as far south as the project site. Their use of inland Washington waters, however, is mostly limited to the Strait of Juan de Fuca. The Navy conducted vessel-based surveys of the waterfront area in 2008-10 (Tannenbaumet al.,2009, 2011). During one of the surveys a Dall's porpoise was sighted in August in the deeper waters off Carlson Spit.

In the absence of an abundance estimate for the entire Hood Canal, a density was derived from the waterfront survey by the number of individuals seen divided by total number of kilometers of survey effort (18 surveys with approximately 3.9 km2[1.5 mi2] of effort each), assuming strip transect surveys. In the absence of any other survey data for the Hood Canal, this density is assumed to be throughout the project area. Exposures were calculated using the formula presented previously. Table 8 depicts the number of estimated behavioral harassments.

Harbor Porpoise

Harbor porpoises may be present in the Hood Canal year-round; their presence had previously been considered rare. During waterfront surveys of NBKB nearshore waters from 2008-10 only one harbor porpoise had been seen in 18 surveys of 3.9 km2each. However, during monitoring of recent Navy actions at NBKB, several sightings indicated that their presence may be more frequent in deeper waters of Hood Canal than had been believed on the basis of existing survey data and anecdotal evidence. Subsequently, the Navy conducted dedicated vessel-based line transect surveys on days when no construction activity occurred (due to security, weather, etc.), described previously in this document, with regular observations of harbor porpoise groups. Sightings in the deeper waters of Hood Canal ranged up to eleven individuals, with an average of approximately six animals sighted per survey day (Navy, in prep.).

Sightings of harbor porpoises during these surveys were used to generate a density for Hood Canal. Based on guidance from other line transect surveys conducted for harbor porpoises using similar monitoring parameters (e.g., boat speed, number of observers) (Barlow, 1988; Calambokidiset al.,1993; Carettaet al.,2001), the Navy determined the effective strip width for the surveys to be 1 km, or aperpendicular distance of 500 m from the transect to the left or right of the vessel. The effective strip width was set at the distance at which the detection probability for harbor porpoises was equivalent to one, which assumes that all individuals on a transect are detected. Only sightings occurring within the effective strip width were used in the density calculation. By multiplying the trackline length of the surveys by the effective strip width, the total area surveyed during the surveys was 259.01 km2. Thirty-five individual harbor porpoises were sighted within this area, resulting in a density of 0.135 animals per km2. To account for availability bias, or the animals which are unavailable to be detected because they are submerged, the Navy utilized a g(0) value of 0.54, derived from other similar line transect surveys (Barlow, 1988; Calambokidiset al.,1993; Carrettaet al.,2001). This resulted in a density of 0.250 harbor porpoises per km2. For comparison, 274.27 km2of trackline survey effort in nearby Dabob Bay produced a corrected density estimate of 0.203 harbor porpoises per km2. Exposures were calculated using the formula described previously. Table 8 depicts the number of estimated behavioral harassments.

Potential takes could occur if individuals of these species move through the area on foraging trips when pile removal is occurring. Individuals that are taken could exhibit behavioral changes such as increased swimming speeds, increased surfacing time, or decreased foraging. Most likely, individuals may move away from the sound source and be temporarily displaced from the areas of pile removal. Potential takes by disturbance would likely have a negligible short-term effect on individuals and not result in population-level impacts.

California sea lion326.20* 390* 320422Steller sea lion31.20* 60* 32092Harbor seal1.310705320737Humpback whale0.003000N/A0Killer whale0.0380150N/A15Dall's porpoise0.0140150N/A15Harbor porpoise0.25001350N/A135Total01,3209601,416* See preceding species-specific discussions for description of take estimate.1Acoustic injury threshold is 190 dB for pinnipeds and 180 dB for cetaceans. No activity would produce source levels equal to 190 dB, while only vibratory removal would produce a source level of 180 dB.2Acoustic disturbance threshold is 100 dB for sea lions and 90 dB for harbor seals. NMFS does not believe that pinnipeds would be available for airborne acoustic harassment because they are known to haul-out only at locations well outside the zone in which airborne acoustic harassment could occur; nevertheless, calculations predict that no incidental take would occur as a result of airborne sound.3Figures presented are abundance numbers, not density, and are calculated as the average of average daily maximum numbers per month. Abundance numbers are rounded to the nearest whole number for take estimation.Negligible Impact and Small Numbers Analysis and Preliminary Determination

NMFS has defined “negligible impact” in 50 CFR 216.103 as “* * * an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” In making a negligible impact determination, NMFS considers a variety of factors, including but not limited to: (1) The number of anticipated mortalities; (2) the number and nature of anticipated injuries; (3) the number, nature, intensity, and duration of Level B harassment; and (4) the context in which the take occurs.

Pile removal activities associated with the wharf rehabilitation project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the proposed activities may result in take, in the form of Level B harassment (behavioral disturbance) only, from underwater sounds generated through pile removal. No mortality, serious injury, or Level A harassment is anticipated given the nature of the activity (i.e., non-pulsed sound with low source levels) and measures designed to minimize the possibility of injury to marine mammals, while Level B harassment would be reduced to the level of least practicable adverse impact for the same reasons. Specifically, these removal methods would produce lower source levels than would pile installation with a vibratory hammer, which does not have significant potential to cause injury to marine mammals due to its sound source characteristics and relatively low source levels. Pile removal would either not start or be halted if marine mammals approach the shutdown zone (described previously in this document). The pile removal activities analyzed here carry significantly less risk of impact to marine mammals than did other construction activities analyzed and monitored within the Hood Canal, including two recent projects conducted by the Navy at the same location (test pile project and the first year of EHW-1 pile replacement work) as well as work conducted in 2005 for the Hood Canal Bridge (SR-104) by the Washington Department of Transportation. These activities have taken place with no reported injuries or mortality to marine mammals.

The proposed numbers of authorized take for marine mammals would be considered small relative to the relevant stocks or populations even if each estimated taking occurred to a new individual—an extremely unlikely scenario. The proposed numbers of authorized take represent 5 percent of the relevant stock for harbor seals, 4.2percent for transient killer whales, and 1.3 percent for harbor porpoises; the proposed numbers are less than 1 percent for the remaining species. However, even these low numbers represent potential instances of take, not the number of individuals taken. That is, it is likely that a relatively small subset of Hood Canal harbor seals, which is itself a small subset of the regional stock, would be harassed by project activities.

For example, while the available information and formula estimate that as many as 737 exposures of harbor seals to stimuli constituting Level B harassment could occur, that number represents some portion of the approximately 1,088 harbor seals resident in Hood Canal (approximately 7 percent of the regional stock) that could potentially be exposed to sound produced by pile removal activities on multiple days during the project. No rookeries are present in the project area, there are no haul-outs other than those provided opportunistically by man-made objects, and the project area is not known to provide foraging habitat of any special importance. Repeated exposures of individuals to levels of sound that may cause Level B harassment are unlikely to result in hearing impairment or to significantly disrupt foraging behavior. Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in viability for Hood Canal harbor seals, and thus would not result in any adverse impact to the stock as a whole.

NMFS has preliminarily determined that the impact of the previously described wharf rehabilitation project may result, at worst, in a temporary modification in behavior (Level B harassment) of small numbers of marine mammals. No injury, serious injury, or mortality is anticipated as a result of the specified activity, and none is proposed to be authorized. Additionally, animals in the area are not expected to incur hearing impairment (i.e., TTS or PTS) or non-auditory physiological effects. For pinnipeds, the absence of any major rookeries and only a few isolated and opportunistic haul-out areas near or adjacent to the project site means that potential takes by disturbance would have an insignificant short-term effect on individuals and would not result in population-level impacts. Similarly, for cetacean species the absence of any known regular occurrence adjacent to the project site means that potential takes by disturbance would have an insignificant short-term effect on individuals and would not result in population-level impacts. Due to the nature, degree, and context of behavioral harassment anticipated, the activity is not expected to impact rates of recruitment or survival.

While the number of marine mammals potentially incidentally harassed would depend on the distribution and abundance of marine mammals in the vicinity of the survey activity, the number of potential harassment takings is estimated to be small relative to regional stock or population number, and has been mitigated to the lowest level practicable through incorporation of the proposed mitigation and monitoring measures mentioned previously in this document. This activity is expected to result in a negligible impact on the affected species or stocks. The eastern DPS of the Steller sea lion is listed as threatened under the ESA; no other species for which take authorization is requested are either ESA-listed or considered depleted under the MMPA.

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, NMFS preliminarily finds that the proposed wharf construction project would result in the incidental take of small numbers of marine mammals, by Level B harassment only, and that the total taking from the activity would have a negligible impact on the affected species or stocks.

Impact on Availability of Affected Species or Stock for Taking for Subsistence Uses

No tribal subsistence hunts are held in the vicinity of the project area; thus, temporary behavioral impacts to individual animals would not affect any subsistence activity. Further, no population or stock level impacts to marine mammals are anticipated or authorized. As a result, no impacts to the availability of the species or stock to the Pacific Northwest treaty tribes are expected as a result of the proposed activities. Therefore, no relevant subsistence uses of marine mammals are implicated by this action.

Endangered Species Act (ESA)

There are two ESA-listed marine mammal species with known occurrence in the project area: The eastern DPS of the Steller sea lion, listed as threatened, and the humpback whale, listed as endangered. Because of the potential presence of these species, the Navy has requested a formal consultation with the NMFS Northwest Regional Office under section 7 of the ESA. NMFS' Office of Protected Resources has also initiated formal consultation on its authorization of incidental take of Steller sea lions. These consultations are in progress. These species do not have critical habitat in the action area.

National Environmental Policy Act (NEPA)

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321et seq.), as implemented by the regulations published by the Council on Environmental Quality (40 CFR parts 1500-1508), and NOAA Administrative Order 216-6, the Navy prepared an Environmental Assessment (EA) to consider the direct, indirect and cumulative effects to the human environment resulting from the pile replacement project. NMFS adopted that EA in order to assess the impacts to the human environment of issuance of an IHA to the Navy. NMFS signed a Finding of No Significant Impact (FONSI) on May 17, 2011. On the basis of new information related to the occurrence of marine mammals in the Hood Canal, the Navy is preparing a supplement to that EA. NMFS will review that document and, if appropriate, issue a new FONSI.

Proposed Authorization

As a result of these preliminary determinations, NMFS proposes to authorize the take of marine mammals incidental to the Navy's wharf rehabilitation project, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice; issuance of a Letter of Authorization (LOA).

SUMMARY:

In accordance with the Marine Mammal Protection Act (MMPA) and implementing regulations, notification is hereby given that a LOA has been issued to the U.S. Department of the Air Force, Headquarters 96th Air Base Wing (U.S. Air Force), Eglin Air Force Base (Eglin AFB) to take marine mammals, by Level B harassment, incidental to Naval Explosive Ordnance Disposal School (NEODS) training operations at Eglin AFB, Florida from approximately April, 2012, to April, 2017. The U.S. Air Force activities are considered military readiness activities pursuant to the MMPA, as amended by the National Defense Authorization Act of 2004 (NDAA).

DATES:

Effective April 23, 2012, through April 24, 2017.

ADDRESSES:

The LOA and supporting documentation are available by writing to P. Michael Payne, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910-3225, by telephoning one of the contacts listed here (seeFOR INFORMATION CONTACT), or online at:http://www.nmfs.noaa.gov/pr/permits/incidental.htm.Documents cited in this notice may be viewed, by appointment, during regular business hours, at the aforementioned address. NMFS has prepared an Environmental Assessment titled “Environmental Assessment on the Promulgation of Regulations and the Issuance of Letters of Authorization to Take Marine Mammals, by Level B Harassment, Incidental to Naval Explosive Ordnance Disposal School Training Operations at Eglin Air Force Base, Florida” (EA) and Finding of No Significant Impact (FONSI) in accordance with the National Environmental Policy Act (NEPA) as implemented by regulations published by the Council on Environmental Quality (CEQ).

Paragraphs 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361et seq.) direct the Secretary of Commerce (Secretary), upon request, to allow for a period of not more than five years, the incidental, but not intentional, taking of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and regulations are issued. Alternatively, if the taking is limited to harassment, certain determinations are made and the authorization does not exceed one year, an IHA may be issued. Upon making a finding that an application for incidental take is adequate and complete, NMFS commences the incidental take authorization process by publishing in theFederal Registera notice of receipt of an application for the implementation of regulations or a proposed IHA initiating a period for public review and comment.

An authorization for the incidental takings may be granted if NMFS finds that the taking during the period for the authorization will have a negligible impact on the species or stock(s) of marine mammals, will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth to achieve the least practicable adverse impact.

NMFS has defined “negligible impact” in 50 CFR 216.103 as: “* * * an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

The National Defense Authorization Act of 2004 (NDAA) (Pub. L. 108-36) modified the MMPA by removing the “small numbers” and “specified geographic region” limitations and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (section 3(18)(B) of the MMPA): “(i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or behavioral patterns are abandoned or significantly altered (Level B harassment).”

Summary of Request

On November 6, 2009, NMFS received an application from the U.S. Air Force requesting an authorization for the take of marine mammals incidental to NEODS training operations. These training operations are properly considered “military readiness activity” under the provisions of the NDAA. On January, 15, 2010, NMFS published notification of receipt (75 FR 2490) in theFederal Registerfor the U.S. Air Force's NEODS training operations and determined that its application was adequate and complete. TheFederal Registernotice solicited comments from the public. After the close of the public comment period and review of comments, NMFS, on October 1, 2010, NMFS published a notification of a proposed rule (75 FR 60694) with the text of the proposed rule in theFederal Registerfor the U.S. Air Force's NEODS training operations. TheFederal Registernotice solicited public comments on the preliminary approach taken in the proposed rule. On November 30, 2010, NMFS received a revised application from the U.S. Air Force which addressed public comments received during the comment period for the proposed rule. The application re-estimated the Zones of Influence (ZOI) and associated takes on revised thresholds for Level A and Level B harassment. On December 5, 2011, NMFS received a revised application from the U.S. Air Force with revised monitoring and mitigation measures to reduce the potential for lethal take of bottlenose dolphins due to an event involving the mortality of common dolphins associated with similar explosive training operations at the U.S. Navy's Silver Strand Training Complex near San Diego, California. On March 22, 2012, NMFS published a notice of final rule (77 FR 16718) and final regulation in theFederal Registerauthorizing take by Level B harassment of Atlantic bottlenose dolphins (Tursiops truncatus) incidental to the U.S. Air Force's NEODS training operations. The final regulations are codified in the Code of Federal Regulations at 50 CFR 217.80-89.

Pursuant to these regulations, NMFS is issuing this LOA to authorize the take, by Level B (behavioral) harassment, of Atlantic bottlenose dolphins incidental to conducting NEODS training operations and testing at Eglin Gulf Test and Training Range (EGTTR) at property off Santa Rosa Island, FL, in the northern Gulf of Mexico (GOM) in accordance with the issuance of one or more Letters of Authorization over a 5-year period. Estimated take would average approximately 10 animals per year; approximately 50 animals over the 5-year period.

Specified Activities

The specified activities covered by this 5-year LOA are identical to those covered in the regulations. NEODSmissions involve underwater detonations of small, live explosive charges adjacent to inert mines. The NEODS may conduct up to eight two-day demolition training events annually; these missions may occur at any time of the year. Each demolition training event involves a maximum of five detonations. Up to 20 five-pound (lb) charges (five lbs net explosive weight [NEW] per charge) and 20 ten-lb charges (ten lbs NEW per charge) would be detonated annually in the GOM, approximately three nautical miles (5.6 kilometers) offshore of Eglin AFB. Detonations would be conducted on the sea floor, adjacent to an inert mine, at a depth of approximately 60 feet (18.3 meters). Additional information on the NEODS training operations is contained in the application and final rule, which is available upon request (seeADDRESSES).

Mitigation and Monitoring

The mitigation and monitoring included in this LOA are identical to those required by the governing regulations. In summary, they include:

(1) The time of detonation will be limited to daylight hours (i.e., an hour after sunrise and an hour before sunset);

(2) NEODS missions would be delayed if the Beaufort sea state is greater than scale number three (i.e., if whitecaps cover more than 50 percent of the surface or waves are greater than 0.9 meters (m) (3 feet [ft]) to ensure visibility of marine mammals to observers);

(3) Time delays longer than 10 minutes will not be used and initiation of the timer device will not start until the mitigation-monitoring zone is clear of marine mammals for 30 minutes;

(4) Observers on boats and/or helicopters will conduct monitoring pre-mission, throughout the mission, and post-mission for the presence of marine mammals and other protected species indicators;

(5) NEODS mission would be postponed or suspended if marine mammals and/or large concentrations of protected species indicators are observed within or about to enter the mitigation-monitoring zone:

(6) After a delay due to the aforementioned wildlife being detected in the mitigation-monitoring zone, the mission would not be continued until the wildlife in question is confirmed to be outside the mitigation-monitoring zone, the animal(s) are moving away from the mission area, and the animal(s) does not re-enter the mitigation-monitoring zone for 30 minutes; and

(7) Post-mission monitoring would be conducted to report any injured, seriously injured, or dead marine mammals.

Negligible Impact Determination

As analyzed and described in further detail in the preamble to the final regulations, taking authorized under the regulations will have a negligible impact on the affected species and stocks of marine mammals.

Authorization

Accordingly, NMFS has issued an LOA to the U.S. Air Force authorizing takes of marine mammals incidental to NEODS training operations at Eglin AFB. Issuance of this LOA was based on NMFS's determination that the total number of marine mammals taken by the activity as a whole shall have no more than a negligible impact on the affected marine mammal species, Atlantic bottlenose dolphin. The basis for this determination is described in the preamble to the final rule (77 FR 16718, March 22, 2012). NMFS also determined that the LOA will not have an unmitigable adverse impact on the availability of the affected marine mammal stocks for subsistence uses.

The Bureau of Consumer Financial Protection (Bureau), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3507(a)(1)(D)). The Bureau is soliciting comments regarding the information collection requirements relating to the Equal Credit Opportunity Act that have been submitted to the Office of Management and Budget for review and approval. A copy of the submission may be obtained by contacting the agency contact listed below.

DATES:

Written comments are encouraged and must be received on or before May 30, 2012 to be assured of consideration.

ADDRESSES:

You may submit comments, identified by OMB number 3170-0013, by any of the following methods:

Abstract:Federal and state enforcement agencies and private litigants use recordkeeping information to, for example, compare accepted and rejected applicants or the terms and conditions of accepted applicants in order to determine whether applicants are treated less favorably on the basis of race, sex, age, or other prohibited bases under the Equal Credit Opportunity Act (ECOA). Information derived from these records provides an important piece of evidence of law violations in ECOA enforcement actions brought by Federal agencies. Self-testing records (including for corrective action) are used by creditors to identify potential violations and reflect their efforts to correct the problem. Absent the Regulation B requirement that creditors retain monitoring information, the CFPB's and other agencies' ability to detect unlawful discrimination and enforce the ECOA would be significantly impaired. The CFPB, other agencies, and private litigants use adverse action notices, appraisal reports, and other information in the application file to compare applicants in order to determine whether any applicants are discriminated against on the basis of race/national origin, sex, marital status, age, or other prohibited bases under the ECOA. The adverse action notice requirement apprises applicants of their rights under the ECOA and of the basis for a creditor's decision. Applicants use their copy of the appraisal to review (and possibly challenge) the accuracyand/or fairness of the information contained within, and to determine the role that the appraisal played in the credit decision. Applicants use the self-testing disclosure to facilitate understanding of creditors' information collection, including its optionality.

The Bureau of Consumer Financial Protection (Bureau), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3507(a)(1)(D)). The Bureau is soliciting comments regarding the information collection requirements relating to the Privacy of Consumer Financial Information that have been submitted to the Office of Management and Budget for review and approval. A copy of the submission may be obtained by contacting the agency contact listed below.

DATES:

Written comments are encouraged and must be received on or before May 30, 2012 to be assured of consideration.

ADDRESSES:

You may submit comments, identified by OMB number 3170-0010, by any of the following methods:

Abstract:Section 502 of the Gramm-Leach-Bliley Act (GLB Act) (Pub. L. 106-102) generally prohibits a financial institution from sharing nonpublic personal information about a consumer with nonaffiliated third parties unless the institution satisfies various disclosure requirements (including provision of initial privacy notices, annual notices, notices of revisions to the institution's privacy policy, and opt-out notices) and the consumer has not elected to opt out of the information sharing. The CFPB is promulgating regulations to implement the GLB Act's notice requirements and restrictions on a financial institution's ability to disclose nonpublic personal information about consumers to nonaffiliated third parties.

The Bureau of Consumer Financial Protection (Bureau or CFPB), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the Bureau is soliciting comments concerning the information collection efforts relating to the Office of Intergovernmental Affairs Outreach Activities.

DATES:

Written comments are encouraged and must be received on or before June 29, 2012 to be assured of consideration.

ADDRESSES:

You may submit comments by any of the following methods:

•Electronic:CFPB_Public_PRA@cfpb.gov.

•Mail/Hand Delivery/Courier:Direct all written comments to Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552. Instructions: All submission should include agency name and proposed collection title. Comments will be available for public inspection and copying at 1700 G Street NW., Washington, DC 20552 on official business days between the hours of 10 a.m. and 5 p.m. Eastern Time. You can make an appointment to inspect comments by telephoning (202) 435-7275. All comments, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. You should only submit information that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information or copies of the documents contained under this approval number should be directed to R. Joseph Durbala, (202) 435-7893, at the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, or through the internet atCFPB_Public_PRA@cfpb.gov.

SUPPLEMENTARY INFORMATION:

Title:CFPB Office of Intergovernmental Affairs Outreach Activities.

OMB Number:3170-XXXX.

Abstract:The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) contemplates that the Bureau will conduct outreach activities, as appropriate. See, e.g., 12 U.S.C. 5495; 12 U.S.C. 5512(c)(1), 12 U.S.C. 5493(d), 12 U.S.C. 5493(b)(2), 12 U.S.C. 5511(c)(6). The Bureau's Office of Intergovernmental Affairs seeks to conduct outreach by collectinginformation from state, local, and tribal governments related to the Bureau's exercise of its functions under the Dodd Frank Act. These governments interact closely with consumers and are critical partners in promoting transparency and competition in the marketplace, preventing unfair and unlawfully discriminatory practices, and enforcing consumer financial laws. The information collected through the Office of Intergovernmental Affairs Outreach Activities will be shared, as appropriate, within the Bureau in the exercise of its functions, such as the Bureau's financial education, rulemaking, market monitoring, outreach to traditionally underserved populations, fair lending monitoring, supervision, and enforcement functions.

The information collected may be used to form policies and programs presented to state, local, and tribal governments, as well as to other federal agencies and the general public. Nearly all information collection will involve the use of electronic communication or other forms of information technology and telephonic means.

Current Actions:Request for new approval of collection activities.

Type of Review:New collection.

Affected Public:State, Local, or Tribal Governments.

Estimated Number of Responses:1,600.

Estimated Time per Respondent:2 hours.

Estimated Total Annual Burden Hours:3,200.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.

Request for Comments:Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

The Bureau of Consumer Financial Protection (Bureau), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3507(a)(1)(D)). The Bureau is soliciting comments regarding the information collection requirements relating to the Mortgage Assistance Relief Services that have been submitted to the Office of Management and Budget for review and approval. A copy of the submission may be obtained by contacting the agency contact listed below.

DATES:

Written comments are encouraged and must be received on or before May 30, 2012 to be assured of consideration.

ADDRESSES:

You may submit comments, identified by OMB number 3170-0008, by any of the following methods:

Abstract:The Home Mortgage Disclosure Act (HMDA) requires most mortgage lenders lending in metropolitan areas to collect data about their housing-related lending activity. Annually, lenders must report those data to the appropriate Federal agencies and make the data available to the public. The CFPB's regulation requires covered financial institutions that meet certain thresholds to maintain data about home loan applications (e.g., the type of loan requested, the purpose of the loan, whether the loan was approved, and the type of purchaser if the loan was later sold), to update the information quarterly, and to report the information annually. The purpose of the information collection is: (i) To help determine whether financial institutions are serving the housing needs of their communities; (ii) to assist public officials in distributing public-sector investment so as to attract private investment to areas where it is needed; and (iii) to assist in identifying possible discriminatory lending patterns and enforcing antidiscrimination statutes.

The information collection will assist the CFPB's examiners, and examiners of other Federal supervisory agencies, in determining that the financial institutions they supervise comply with applicable provisions of HMDA.

The Bureau of Consumer Financial Protection (Bureau), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take thisopportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3507(a)(1)(D)). The Bureau is soliciting comments regarding the information collection requirements relating to the Interstate Land Sales Full Disclosure Act that have been submitted to the Office of Management and Budget for review and approval. A copy of the submission may be obtained by contacting the agency contact listed below.

DATES:

Written comments are encouraged and must be received on or before May 30, 2012 to be assured of consideration.

ADDRESSES:

You may submit comments, identified by OMB number 3170-0012, by any of the following methods:

Abstract:The respondents are land developers (or attorneys or others who work for them). Developers must submit an initial Statement of Record (registration) to the CFPB and receive an effective date before they can offer lots for sale or lease. The Statement of Record includes the proposed property report and additional information and documents that support the developer's disclosures in the property report. The developer is responsible for ensuring that the registration is accurate and does not omit information needed for a purchaser to make an informed decision. Developers must give purchasers an effective property report before the purchaser signs the sales contract. Developers must submit amendments to their registrations if any information in their initial registration changes. They must also submit a consolidated filing if they offer additional lots for sale. Each year the developer must submit an annual financial statement and an annual report that is prepared in the format required by Section 1010.310 of the regulations. A developer may voluntarily suspend his registration by submitting a Voluntary Suspension form or through the Annual Report. There are no other forms. The CFPB conducts a facial review of the submissions. The developer may request an Advisory Opinion if a developer has questions about the applicability of one of the exemptions from registration. A CFPB determination is required only if a developer claims an exemption from registration under the multiple site or substantial compliance exemption. The other 24 exemptions are self-determining. Finally, the CFPB may require additional information from developers in response to investigations of complaints. The Voluntary Suspension form is voluntary and is a convenient way for developers to voluntarily suspend their registration. The form is not required and is not the only way that developers may close their registration. They may also end their registration through their annual report.

The Bureau of Consumer Financial Protection (Bureau), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3507(a)(1)(D)). The Bureau is soliciting comments regarding the information collection requirements relating to the Truth in Lending Act that have been submitted to the Office of Management and Budget for review and approval. A copy of the submission may be obtained by contacting the agency contact listed below.

DATES:

Written comments are encouraged and must be received on or before May 30, 2012 to be assured of consideration.

ADDRESSES:

You may submit comments, identified by OMB number 3170-0015, by any of the following methods:

Abstract:Federal and state enforcement agencies and private litigants use records retained under the requirement of Regulation Z to ascertain whether accurate and complete disclosures of the cost of credit have been provided to consumers prior to consummation of the credit obligation and, in some instances, during the loan term. The information is also used to determine whether other actions required under the TILA, including complying with billing error resolution procedures and limitation of consumer liability for unauthorized use of credit, have been met. The information retained provides the primary evidence of law violations in TILA enforcement actions brought by Federal agencies. Without the Regulation Z recordkeeping requirement, the agencies' ability to enforce the TILA would be significantly impaired. As noted above, consumers rely on the disclosures required by the TILA and Regulation Z to shop amongoptions and to facilitate informed credit decision making. Without this information, consumers would be severely hindered in their ability to assess the true costs and terms of financing offered. Also, without the special billing error information, consumers would be unable to detect and correct errors or fraudulent charges on their open-end credit accounts. Additionally, enforcement agencies and private litigants need the information in these disclosures to enforce the TILA and Regulation Z. See 15 U.S.C. 1607, 1640.

The Bureau of Consumer Financial Protection (Bureau), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the Bureau is soliciting comments concerning the information collection efforts relating to streamlining inherited regulations.

DATES:

Written comments should be received on or before June 29, 2012 to be assured of consideration.

Instructions:Comments will be available for public inspection and copying at 1700 G Street NW., Washington, DC 20552 on official business days between the hours of 10 a.m. and 5 p.m. Eastern Time. You can make an appointment to inspect comments by telephoning (202) 435-7275. All comments, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. You should only submit information that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information or copies of the documents contained under this approval number should be directed to R. Joseph Durbala, (202) 435-7893, at the Consumer Financial Protection Bureau, (Attention: R. Joseph Durbala, PRA Office),1700 G Street NW., Washington, DC 20552, or through the internet atCFPB_Public_PRA@cfpb.gov.

SUPPLEMENTARY INFORMATION:

Title:Streamlining Inherited Regulations.

OMB Number:3170-0020.

Form Number:N/A.

Abstract:The purpose of this data collection is to help the Bureau identify priority areas for such streamlining. The Bureau's effort to identify and address such priorities is and will continue to be based in part on guidance provided by the Office of Management and Budget Memorandum for the Heads of Independent Regulatory Agencies, M-11-28, “Executive Order 13579, `Regulation and Independent Regulatory Agencies'” (July 22, 2011). That guidance discusses the importance of opportunities for public participation in the development of any retrospective analysis plan. Consistent with this guidance, the Bureau seeks to reach interested parties through two mechanisms. The first mechanism is aFederal Registernotice. On December 5, 2011, a notice titled “Streamlining Inherited Regulations” was published in theFederal Register. The notice seeks comment in writing, or through the regulations.gov Web site. The data collection for which the Bureau now seeks approval would be the second mechanism. In order to reach respondents that might not be inclined to respond to theFederal Registernotice, the Bureau seeks to collect input from interested parties through a specialized web tool on the CFPB Web site.

Current Actions:There is no change in the paperwork burden previously approved by OMB. This form is being submitted for renewal purposes only.

Type of Review:Extension of a currently approved collection.

Affected Public:Individuals and Households.

Estimated Number of Responses:500.

Estimated Time per Respondent:1 hour.

Estimated Total Annual Burden Hours:500.

The following paragraph applies to all of the collections of information covered by this notice:

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.

Request for Comments:Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

The Per Diem, Travel and Transportation Allowance Committee is publishing Civilian Personnel Per Diem Bulletin Number 281. This bulletin lists revisions in the per diem rates prescribed for U.S. Government employees for official travel in Alaska, Hawaii, Puerto Rico, the NorthernMariana Islands and Possessions of the United States. AEA changes announced in Bulletin Number 194 remain in effect. Bulletin Number 281 is being published in theFederal Registerto assure that travelers are paid per diem at the most current rates.

DATES:

Effective Date:May 1, 2012.

FOR FURTHER INFORMATION CONTACT:

Mrs. Sonia Malik, 571-372-1276.

SUPPLEMENTARY INFORMATION:

This document gives notice of revisions in per diem rates prescribed by the Per Diem Travel and Transportation Allowance Committee for non-foreign areas outside the continental United States. It supersedes Civilian Personnel Per Diem Bulletin Number 280. Distribution of Civilian Personnel Per Diem Bulletins by mail was discontinued. Per Diem Bulletins published periodically in theFederal Registernow constitute the only notification of revisions in per diem rates to agencies and establishments outside the Department of Defense. For more information or questions about per diem rates, please contact your local travel office. The text of the Bulletin follows: The changes in Civilian Bulletin 281 are updated rates for Hawaii and the Midway Islands.

Office of Elementary and Secondary Education, Department of Education.

ACTION:

Notice.

Overview Information:Territories and Freely Associated States Education Grant Program; Notice inviting applications for new awards for fiscal year (FY) 2012.

Catalog of Federal Domestic Assistance (CFDA) Number: 84.256A.DATES:

Applications Available:April 30, 2012.

Deadline for Transmittal of Applications:June 29, 2012.

Deadline for Intergovernmental Review:August 28, 2012.

Full Text of AnnouncementI. Funding Opportunity Description

Purpose of Program:The Territories and Freely Associated States Education Grant (T&FASEG) program supports projects to raise student achievement through direct educational services. Grants are awarded competitively to local educational agencies (LEAs) in the U.S. Territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and the Virgin Islands) and the Republic of Palau. The LEA may use grant funds to carry out activities authorized by the Elementary and Secondary Education Act of 1965, as amended (ESEA), including teacher training, curriculum development, the development or acquisition of instructional materials, and general school improvement and reform.

Under the T&FASEG program the Secretary awards grants for projects to—

(a) Conduct activities consistent with the programs described in the ESEA, including the types of activities authorized under—

(1) Title I of the ESEA—Improving the Academic Achievement of the Disadvantaged.

(2) Title II of the ESEA—Preparing, Training, and Recruiting High-Quality Teachers and Principals.

(3) Title III of the ESEA—Language Instruction for Limited English Proficient and Immigrant Students.

(4) Title IV of the ESEA—21st Century Schools.

(5) Title V of the ESEA—Promoting Informed Parental Choice and Innovative Programs; and

(b) Provide direct educational services that assist all students with meeting challenging State academic achievement standards.

Note:

The Secretary interprets the term “direct educational services” to mean—

(1) Activities that are designed to improve student achievement or the quality of education; and

(2) Instructional services for students and teacher training.

Priorities:Under this competition we are particularly interested in applications that address the following priorities.

Invitational Priorities:For FY 2012, these priorities are invitational priorities. Under 34 CFR 75.105(c)(1), we do not give an application that meets these invitational priorities a competitive or absolute preference over other applications.

These priorities are:

Priority 1—Standards and Assessments.

The Secretary is particularly interested in receiving applications that focus on developing standards in reading and language arts and mathematics that build toward college- and career-readiness by the time students graduate from high school. The Secretary encourages the development or use, or both, of a new generation of assessments that align with the college- and career-ready standards and that will better determine whether students have acquired the skills needed for success.

Priority 2—Effective Teachers and Leaders.

The Secretary is particularly interested in receiving applications that focus on recruiting and improving the effectiveness of teachers, principals, and administrative leaders through professional development and training in order to better meet the needs of students, especially students in high-need schools. Further, the Secretary is interested in receiving applications that focus on developing pathways and practices for preparing, placing, and supporting beginning teachers and principals in high-need schools.

Priority 3—Technology.

The Secretary is particularly interested in LEA projects that are designed to improve student achievement or teacher effectiveness through the use of high-quality digital tools or materials, which may include preparing teachers to use the technology to improve instruction, as well as developing, implementing, or evaluating digital tools or materials.

Estimated Available Funds:$4,750,000 of FY 2011 funds are available for new awards in FY 2012.

Estimated Range of Awards:$800,000 to $1,000,000.

Estimated Average Size of Awards:$900,000.

Estimated Number of Awards:4-6.

Note:

The Department is not bound by any estimates in this notice.

Project Period:Up to 36 months.

III. Eligibility Information

1.Eligible Applicants:LEAs in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the U.S. Virgin Islands, and the Republic of Palau.

2.Cost Sharing or Matching:This competition does not require cost sharing or matching.

IV. Application and Submission Information

1.Address to Request Application Package:You can obtain the application package electronically by downloading it from the Territories and Freely Associated States Education Grant program Web site:http://www2.ed.gov/programs/tfasegp/applicant.html.

If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the program contact person listed in this section.

2.Content and Form of Application Submission:Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the application narrative to no more than 35 pages, using the following standards:

• A “page” is 8.5″ x 11″, on one side only, with 1” margins at the top, bottom, and both sides.

• Double space (no more than three lines per vertical inch) all text in theapplication narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.

• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).

• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.

The page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the page limit does apply to all of the application narrative section [Part III].

Our reviewers will not read any pages of your application that exceed the page limit.

3.Submission Dates and Times:

Applications Available:April 30, 2012.

Deadline for Transmittal of Applications:June 29, 2012.

Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 7.Other Submission Requirementsof this notice.

We do not consider an application that does not comply with the deadline requirements.

Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed underFOR FURTHER INFORMATION CONTACTin section VII of this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

Deadline for Intergovernmental Review:August 28, 2012.

4.Intergovernmental Review:This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

6.Data Universal Numbering System Number, Taxpayer Identification Number, and Central Contractor Registry:To do business with the Department of Education, you must—

a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database;

c. Provide your DUNS number and TIN on your application; and

d. Maintain an active CCR registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one business day.

If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2-5 weeks for your TIN to become active.

The CCR registration process may take five or more business days to complete. If you are currently registered with the CCR, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your CCR registration on an annual basis. This may take three or more business days to complete.

In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:www.grants.gov/applicants/get_registered.jsp.

7.Other Submission Requirements:

Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

a.Electronic Submission of Applications.

Applications for grants under the Territories and Freely Associated States Education Grant Program competition, CFDA number 84.256A, must be submitted electronically using the Governmentwide Grants.gov Apply site atwww.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirementandsubmit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section underException to Electronic Submission Requirement.

You may access the electronic grant application for the Territories and Freely Associated States Education Grant competition atwww.Grants.gov. You must search for the downloadable application package for this competition by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.256, not 84.256A).

Please note the following:

• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection.Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page athttp://www.G5.gov.

• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

• You must upload any narrative sections and all other attachments to your application as files in a PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material.

• Your electronic application must comply with any page-limit requirements described in this notice.

• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).

• We may request that you provide us original signatures on forms at a later date.

Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System:If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed underFOR FURTHER INFORMATION CONTACTin section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that that problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. The Department will contact you after a determination is made on whether your application will be accepted.

Note:

The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

Exception to Electronic Submission Requirement:You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because--

• You do not have access to the Internet; or

• You do not have the capacity to upload large documents to the Grants.gov system; and

• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevent you from using the Internet to submit your application.

If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

b.Submission of Paper Applications by Mail.

If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.256A), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

You must show proof of mailing consisting of one of the following:

(1) A legibly dated U.S. Postal Service postmark.

(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

(3) A dated shipping label, invoice, or receipt from a commercial carrier.

(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

(1) A private metered postmark.

(2) A mail receipt that is not dated by the U.S. Postal Service.

If your application is postmarked after the application deadline date, we will not consider your application.

Note:

The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

c.Submission of Paper Applications by Hand Delivery.

If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department byhand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.256A), 550 12th Street SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260.

(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

V. Application Review Information

1.Selection Criteria:The selection criteria for this competition are from 34 CFR 75.210. The maximum score for each criterion is indicated after the title of the criterion. The maximum score for all selection criteria is 100 points.

As provided for in section 1121(b)(3)(B) of the ESEA, the Secretary, in making awards under this program, will take into consideration the recommendations of Pacific Region Educational Laboratory (PREL). PREL will use the following criteria in developing its recommendations, and the Secretary will use them in making final funding decisions. The notes following the selection criteria are meant to serve as guidance to assist the applicant in creating a stronger application and are not required by statute or regulation.

(a)Need for project.(5 points)

(1) The Secretary considers the need for the proposed project. (34 CFR 75.210(a)(1)).

(2) In determining the need for the proposed project, the Secretary considers the following factors:

(i) The magnitude or severity of the problem to be addressed by the proposed project. (34 CFR 75.210(a)(2)(i)).

(ii) The magnitude of the need for the services to be provided or the activities to be carried out by the proposed project. (34 CFR 75.210(a)(2)(ii)).

(iii) The extent to which the proposed project will provide services or otherwise address the needs of students at risk of educational failure. (34 CFR 75.210(a)(2)(iii)).

Note:

In addressing this criterion, applicants may want to consider including in the project narrative information that clearly demonstrates the unique needs and circumstances that justify funding support for their project. Applicants may also consider including information to demonstrate the extent to which local resources are used to meet the needs addressed by the project proposal.

(b)Significance.(10 points)

(1) The Secretary considers the significance of the proposed project. (34 CFR 75.210(b)(1)).

(2) In determining the significance of the proposed project, the Secretary considers the following factors:

(i) The national significance of the proposed project. (34 CFR 75.210(b)(2)(i)).

(ii) The significance of the problem or issue to be addressed by the proposed project. (34 CFR 75.210(b)(2)(ii)).

(iii) The importance or magnitude of the results or outcomes likely to be attained by the proposed project, especially improvements in teaching and student achievement. (34 CFR 75.210(b)(2)(xiv)).

(c)Quality of the project design.(25 points)

(1) The Secretary considers the quality of the design of the proposed project. (34 CFR 75.210(c)(1)).

(2) In determining the quality of the design of the proposed project, the Secretary considers the following factors:

(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable. (34 CFR 75.210(c)(2)(i)).

(ii) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs. (34 CFR 75.210(c)(2)(ii)).

(iii) The extent to which the proposed project will be coordinated with similar or related efforts, and with other appropriate community, State, and Federal resources. (34 CFR 75.210(c)(2)(xvi)).

(iv) The extent to which the proposed project is part of a comprehensive effort to improve teaching and learning and support rigorous academic standards for students. (34 CFR 75.210(c)(2)(xviii)).

(vi) The extent to which performance feedback and continuous improvement are integral to the design of the proposed project. (34 CFR 75.210(c)(2)(xxi)).

(d)Adequacy of resources.(5 points)

(1) The Secretary considers the adequacy of resources for the proposed project. (34 CFR 75.210(f)(1)).

(2) In determining the adequacy of resources for the proposed project, the Secretary considers the following factors:

(i) The extent to which the budget is adequate to support the proposed project. (34 CFR 75.210(f)(2)(iii)).

(ii) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project. (34 CFR 75.210(f)(2)(iv)).

(iii) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits. (34 CFR 75.210(f)(2)(v)).

(e)Quality of project personnel.(15 points)

(1) The Secretary considers the quality of the personnel who will carry out the proposed project. (34 CFR 75.210(e)(1)).

(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (34 CFR 75.210(e)(2)).

(3) In addition, the Secretary considers the following factors:

(i) The qualifications, including relevant training and experience, of the project director or principal investigator. (34 CFR 75.210(e)(3)(i)).

(iii) The qualifications, including relevant training and experience, of project consultants or subcontractors. (34 CFR 75.210(e)(3)(iii)).

Note:

In addressing this criterion, applicants may want to consider including curriculum vitae and resumes of key project personnel.

(f)Quality of the project evaluation.(25 points)

(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project. (34 CFR 75.210(h)(1)).

(2) In determining the quality of the evaluation, the Secretary considers the following factors:

(i) The extent to which the methods of evaluation provide for examining theeffectiveness of project implementation strategies. (34 CFR 75.210(h)(2)(iii)).

(ii) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible. (34 CFR 75.210(h)(2)(iv)).

Note:

In addressing this criterion, applicants may want to consider aligning their evaluations with the performance measures described in section VI. 4 of this notice.

(g)Quality of project services.(15 points)

(1) The Secretary considers the quality of the services to be provided by the proposed project. (34 CFR 75.210(d)(1)).

(2) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (34 CFR 75.210(d)(2)).

(3) In addition, the Secretary considers the following factors:

(i) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services. (34 CFR 75.210(d)(3)(i)).

(ii) The likely impact of the services to be provided by the proposed project on the intended recipients of those services. (34 CFR 75.210(d)(3)(iv)).

(iii) The extent to which the training or professional development services to be provided by the proposed project are of sufficient quality, intensity, and duration to lead to improvements in practice among the recipients of those services. (34 CFR 75.210(d)(3)(v)).

(iv) The extent to which the services to be provided by the proposed project are focused on those with greatest needs. (34 CFR 75.210(d)(3)(xi)).

2.Review and Selection Process:We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

3.Special Conditions:Under 34 CFR 74.14 and 80.12, the Secretary may impose special conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 34 CFR parts 74 or 80, as applicable; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

VI. Award Administration Information

1.Award Notices:If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN). We may notify you informally, also.

If your application is not evaluated or not selected for funding, we notify you.

2.Administrative and National Policy Requirements:We identify administrative and national policy requirements in the application package and reference these and other requirements in theApplicable Regulationssection of this notice.

We reference the regulations outlining the terms and conditions of an award in theApplicable Regulationssection of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

3.Reporting:(a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go towww.ed.gov/fund/grant/apply/appforms/appforms.html.

4.Performance Measures:The Department has developed the following three performance measures for evaluating the effectiveness of the T&FASEG program:

(1) The percentage of teachers participating in professional development activities under the T&FASEG program who demonstrate progress toward State teacher certification;

(2) The percentage of students participating in reading programs under the T&FASEG program who score proficient or above in reading on State assessments; and

(3) The percentage of students participating in mathematics programs under the T&FASEG program who score proficient or above in mathematics on State assessments.

These measurements constitute the Department's indicators of success for this program. Consequently, we advise an applicant for a grant under this program to give careful consideration to these measures in conceptualizing the approach and evaluation for its proposed project. Each grantee will be required to provide, in its annual performance and final reports, data about its progress in meeting these measures.

5.Continuation Awards:In making a continuation award, the Secretary may consider, under 34 CFR 75.253, the extent to which a grantee has made “substantial progress toward meeting the objectives in its approved application.” This consideration includes the review of a grantee's progress in meeting the targets and projected outcomes in its approved application, and whether the grantee has expended funds in a manner that is consistent with its approved application and budget. In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

VIII. Other Information

Accessible Format:Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed underFOR FURTHER INFORMATION CONTACTin section VII of this notice.

Electronic Access to This Document:The official version of this document is the document published in theFederal Register. Free Internet access to the official edition of theFederal Registerand the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in theFederal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in theFederal Registerby using the article search feature at:www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Notice inviting applications for new awards for fiscal year (FY) 2011 funds.

Catalog of Federal Domestic Assistance (CFDA) Number: 84.368A-1.

DATES:

Applications Available:April 30, 2012.

Deadline for Notice of Intent to Apply:May 30, 2012.

Deadline for Transmittal of Applications:June 14, 2012.

Deadline for Intergovernmental Review:August 13, 2012.

Full Text of AnnouncementI. Funding Opportunity Description

Purpose of Program:The purpose of the Enhanced Assessment Instruments Grant program, also called the Enhanced Assessment Grants (EAG) program, is to enhance the quality of assessment instruments and systems used by States for measuring the academic achievement of elementary and secondary school students.

In 2012, the Department is holding two separate competitions for FY 2011 EAG funds. The competition announced in this notice (EAG ELP Competition) (CFDA No. 84.368A-1) will support the development of a system of English language proficiency assessments aligned with a common set of English language proficiency standards that correspond to a common set of college- and career-ready standards in English language arts and mathematics, and, in so doing, will give priority to collaborative efforts among States in developing these assessments. Elsewhere in this issue of theFederal Register, we are publishing a notice inviting applications for a separate competition for FY 2011 EAG funds to be awarded in 2012 (EAG Accessibility Competition) (CFDA No. 84.368A-2). The Department may use any unused funds from the competition announced in this notice to make awards in the EAG Accessibility Competition. Conversely, the Department may use any unused funds from the EAG Accessibility Competition to make awards in the competition announced in this notice.

Priorities:This competition includes five absolute priorities and one competitive preference priority. In accordance with 34 CFR 75.105(b)(2)(iv), absolute priorities 1 through 4 (Statutory Priorities) are based on section 6112 of the Elementary and Secondary Education Act of 1965, as amended (ESEA) (20 U.S.C. 7301a). Absolute priority 5 (Regulatory Priority) and competitive preference priority 1 are from the notice of final priorities, requirements, definitions, and selection criteria published in theFederal Registeron April 19, 2011 (76 FR 21986).

Absolute Priorities:For awards made from this competition in 2012 with FY 2011 funds, and any subsequent year in which we make awards from the list of unfunded applicants from this competition, these priorities are absolute priorities. Under 34 CFR 75.105(c)(3) we consider only applications that meet: (a) one or more of the Statutory Priorities (Absolute Priorities 1 through 4) and (b) the Regulatory Priority (Absolute Priority 5).

These priorities are:

Absolute Priority 1—Collaboration.Collaborate with institutions of higher education, other research institutions, or other organizations to improve the quality, validity, and reliability of State academic assessments beyond the requirements for these assessments described in section 1111(b)(3) of the ESEA.

To meet this priority, an applicant must propose a comprehensive plan to develop an English language proficiency assessment system that is valid, reliable, and fair for its intended purpose. Such a plan must include the following features:

(a)Design.The assessment system must—

(1) Be designed for implementation in multiple States;

(2) Be based on a common definition ofEnglish learneradopted by the applicant State and, if the applicant applies as part of a consortium, adopted and held in common by all States in the consortium, where common with respect to the definition of “English learner” means identical for purposes of the diagnostic (e.g., screener or placement) assessments and associated achievement standards used to classify students as English learners as well as the summative assessments and associated achievement standards used to exit students from English learner status;

(3) At a minimum, include diagnostic (e.g., screener or placement) and summative assessments;

(4) Measure students' English proficiency against a set of English language proficiency standards held bythe applicant State and, if the applicant applies as part of a consortium, held in common by all States in the consortium;

(5) Measure students' English proficiency against a set of English language proficiency standards that correspond to a common set of college- and career-ready standards (as defined in this notice) in English language arts and mathematics, are rigorous, are developed with broad stakeholder involvement, are vetted with experts and practitioners, and for which external evaluations have documented rigor and correspondence with a common set of college- and career-ready standards in English language arts and mathematics;

(6) Cover the full range of the English language proficiency standards across the four language domains of reading, writing, speaking, and listening, as required by section 3113(b)(2) of the ESEA;

(7) Ensure that the measures of students' English proficiency consider the students' control over the linguistic components of language (e.g., phonology, syntax, morphology);

(8) Produce results that indicate whether individual students have attained the English proficiency necessary to participate fully in academic instruction in English and meet or exceed college- and career-ready standards;

(9) Provide at least an annual measure of English proficiency and student progress in learning English for English learners in kindergarten through grade 12 in each of the four language domains of reading, writing, speaking, and listening;

(10) Assess all English learners, including English learners who are also students with disabilities and students with limited or no formal education, except for English learners with the most significant cognitive disabilities who are eligible to participate in alternate assessments based on alternate academic achievement standards in accordance with 34 CFR 200.6(a)(2); and

(11) Be accessible to all English learners, including by providing appropriate accommodations for English learners with disabilities, except for English learners with the most significant cognitive disabilities who are eligible to participate in alternate assessments based on alternate academic achievement standards in accordance with 34 CFR 200.6(a)(2).

(b)Technical quality.The assessment system must measure students' English proficiency in ways that—

(1) Are consistent with nationally recognized professional and technical standards; and

(1) Include student attainment of English proficiency and student progress in learning English (including data disaggregated by English learner subgroups such as English learners by years in a language instruction educational program; English learners whose formal education has been interrupted; students who were formerly English learners by years out of the language instruction educational program; English learners by level of English proficiency, such as those who initially scored proficient on the English language proficiency assessment; English learners by disability status; and English learners by native language);

(2) Provide a valid and reliable measure of students' abilities in each of the four language domains (reading, writing, speaking, and listening) and a comprehensive English proficiency score based on all four domains, with each language domain score making a significant contribution to the comprehensive ELP score, at each proficiency level; and

(3) Can be used for the—

(i) Identification of students as English learners;

(ii) Decisions about whether a student should exit from English language instruction educational programs;

(iii) Determinations of school, local educational agency, and State effectiveness for the purposes of accountability under Title I and Title III of the ESEA;

(4) Can be used, as appropriate, as one of multiple measures, to inform—

(i) Evaluations of individual principals and teachers in order to determine their effectiveness;

(ii) Determinations of principal and teacher professional development and support needs; and

(d)Compatibility.The assessment system must use compatible approaches to technology, assessment administration, scoring, reporting, and other factors that facilitate the coherent inclusion of the assessments within States' student assessment systems.

(e)Students with the most significant cognitive disabilities.The comprehensive plan to develop an English language proficiency assessment system must include the strategies the applicant State and, if the applicant is part of a consortium, all States in the consortium, plans to use to assess the English proficiency of English learners with the most significant cognitive disabilities who are eligible to participate in alternate assessments based on alternate academic achievement standards in accordance with 34 CFR 200.6(a)(2) in lieu of including those students in the operational administration of the assessments developed for other English learners under a grant from this competition.

Competitive Preference Priority:For awards made in 2012 with FY 2011 funds, and any subsequent year in which we make awards from the list of unfunded applicants from this competition, this priority is a competitive preference priority. Under 34 CFR 75.105(c)(2)(i) we award up to an additional 5 points to an application, depending on how well the application meets this priority.

This priority is:

Competitive Preference Priority 1—Collaborative Efforts Among States.

To meet this priority, an applicant must—

(a) Include a minimum of 15 States in the consortium;

(b) Identify in its application a proposed project management partner and provide an assurance that the proposed project management partner is not partnered with any other eligible applicant applying for an award under this competition;1

1In selecting a proposed project management partner, an eligible applicant must comply with the requirements for procurement in 34 CFR 80.36.

(c) Provide a description of the consortium's structure and operation. The description must include—

(1) The organizational structure of the consortium (e.g., differentiated roles that a member State may hold);

(2) The consortium's method and process (e.g., consensus, majority) for making different types of decisions (e.g., policy, operational);

(3) The protocols by which the consortium will operate, including protocols for member States to change roles in the consortium, for member States to leave the consortium, and for new member States to join the consortium;

(4) The consortium's plan, including the process and timeline, for setting key policies and definitions for implementing the proposed project, including, for any assessments developed through a project funded by this grant, the common set of standards upon which to base the assessments, acommon set of performance-level descriptors, a common set of achievement standards, common assessment administration procedures, common item-release and test-security policies, and a common set of policies and procedures for accommodations and student participation; and

(5) The consortium's plan for managing grant funds received under this competition; and

(d) Provide a memorandum of understanding or other binding agreement executed by each State in the consortium that includes an assurance that, to remain in the consortium, the State will adopt or use any instrument, including to the extent applicable, assessments, developed under the proposed project no later than the end of the project period.

Requirements:The following requirements, which were published in theFederal Registeron April 19, 2011 (76 FR 21986), apply to this competition. An eligible applicant awarded a grant under this program must:

(a) Evaluate the validity, reliability, and fairness of any assessments or other assessment-related instruments developed under a grant from this competition, and make available documentation of evaluations of technical quality through formal mechanisms (e.g., peer-reviewed journals) and informal mechanisms (e.g., newsletters), both in print and electronically;

(b) Actively participate in any applicable technical assistance activities conducted or facilitated by the Department or its designees, coordinate with the RTTA program in the development of assessments under this program, and participate in other activities as determined by the Department;

(c) Develop a strategy to make student-level data that result from any assessments or other assessment-related instruments developed under a grant from this competition available on an ongoing basis for research, including for prospective linking, validity, and program improvement studies;2

2Eligible applicants awarded a grant under this program must comply with the Family Educational Rights and Privacy Act (FERPA) and 34 CFR part 99, as well as State and local requirements regarding privacy.

(d) Ensure that any assessments or other assessment-related instruments developed under a grant from this competition will be operational (ready for large-scale administration) at the end of the project period;

(e) Ensure that funds awarded under the EAG program are not used to support the development of standards, such as under the English language proficiency assessment system priority or any other priority.

(f) Maximize the interoperability of any assessments and other assessment-related instruments developed with funds from this competition across technology platforms and the ability for States to move their assessments from one technology platform to another by doing the following, as applicable, for any assessments developed with funds from this competition by—

(1) Developing all assessment items in accordance with an industry-recognized open-licensed interoperability standard that is approved by the Department during the grant period, without non-standard extensions or additions; and

(2) Producing all student-level data in a manner consistent with an industry-recognized open-licensed interoperability standard that is approved by the Department during the grant period;

(g) Unless otherwise protected by law or agreement as proprietary information, make any assessment content (i.e., assessments and assessment items) and other assessment-related instruments developed with funds from this competition freely available to States, technology platform providers, and others that request it for purposes of administering assessments, provided that those parties receiving assessment content comply with consortium or State requirements for test or item security; and

(h) For any assessments and other assessment-related instruments developed with funds from this competition, use technology to the maximum extent appropriate to develop, administer, and score the assessments and report results.

Definitions:The following definitions, which were published in theFederal Registeron April 19, 2011 (76 FR 21986), apply to this competition.

Common set of college- and career-ready standardsmeans a set of academic content standards for grades K-12 held in common by multiple States, that (a) define what a student must know and be able to do at each grade level; (b) if mastered, would ensure that the student is college- and career-ready by the time of high school graduation; and (c) for any consortium of States applying under the EAG program, are substantially identical across all States in the consortium.

A State in a consortium may supplement the common set of college- and career-ready standards with additional content standards, provided that the additional standards do not comprise more than 15 percent of the State's total standards for that content area.

English language proficiency assessment system,for purposes of the English language proficiency assessment system priority, means a system of assessments that includes, at a minimum, diagnostic (e.g., screener or placement) and summative assessments at each grade level from kindergarten through grade 12 that cover the four language domains of reading, writing, speaking, and listening, as required by section 3113(b)(2) of the ESEA, and that meets all other requirements of the priority.

English learnermeans a student who is an English learner as defined by the applicant consistent with the definition of a student who is “limited English proficient” as that term is defined in section 9101(25) of the ESEA. If the applicant submits an application on behalf of a consortium, member States must develop and adopt a common definition of the term during the period of the grant.

Student with a disabilitymeans a student who has been identified as a child with a disability under the Individuals with Disabilities Education Act, as amended.

Program Authority:

20 U.S.C. 7301a and 7842.

Applicable Regulations:(a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 74, 75, 77, 80, 81, 82, 84, 86, 97, 98, and 99. (b) The Debarment and Suspension regulations in 2 CFR part 3485. (c) The notice of final priorities, requirements, definitions, and selection criteria published in theFederal Registeron April 19, 2011 (76 FR 21986). (d) The notice of final revision to selection criteria, published elsewhere in this issue of theFederal Register.

Note:

The regulations in 34 CFR part 86 apply to institutions of higher education only.

II. Award Information

Type of Award:Discretionary grants.

Estimated Available Funds:$6,000,000 in FY 2011 funds to be awarded in 2012. Contingent upon the availability of funds and the quality of applications, we may make additional awards with FY 2012 funds from the list of unfunded applicants from this competition.

Estimated Range of Awards:$5,000,000 to $7,000,000.

Estimated Average Size of Awards:$6,000,000.

Estimated Number of Awards:1.

Note:

Applicants should submit a single budget request for a single budget and project period of up to 48 months. Subject to the availability of future years' funds, the Department may make supplemental grant awards to the grants awarded with FY 2011 funds.

Note:

The Department is not bound by any estimates in this notice.

Project Period:Up to 48 months.

III. Eligibility Information

1.Eligible Applicants:State educational agencies (SEAs) as defined in section 9101(41) of the ESEA and consortia of such SEAs.

2.Cost Sharing or Matching:This competition does not require cost sharing or matching.

3.Other:An application from a consortium of SEAs must designate one SEA as the fiscal agent.

IV. Application and Submission Information

1.Address to Request Application Package:You can access the electronic grant application for the Enhanced Assessment Instruments Grants Program athttp://www.Grants.gov. You must search for the downloadable application package for this competition by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.368, not 84.368A). Your search will result in two grant opportunities; be sure to select the opportunity for the EAG ELP Competition application package. You can also obtain a copy of the application package by contacting the program contact persons listed underAgency Contactsin section VII of this notice.

Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the person listed underAccessible Formatin section VIII of this notice.

2.Content and Form of Application Submission:Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this competition.

Page Limit: The project narrative (Part 3 of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application and the absolute and competitive preference priorities. You must limit the project narrative (Part 3) to the equivalent of no more than 65 pages, using the following standards:

• A “page” is 8.5″ x 11″, on one side only, with 1” margins at the top, bottom, and both sides.

• Double space (no more than three lines per vertical inch) all text in the project narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.

• Times New Roman font no smaller than 11.0 point for all text in the project narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables figures, and graphs. (Font sizes that are smaller than 11 but round up to 11, such as 10.7 point, will be considered smaller than 11.0.)

• Any screen shots included as part of the narrative should follow these standards or, if other standards are applied, be sized to equal the equivalent amount of space if these standards were applied.

The page limit applies to the project narrative (Part 3), including the table of contents, which must include a discussion of how the application meets one or more of the statutory absolute priorities and how well the applicant meets the regulatory absolute priority; if applicable, how the application meets the competitive preference priority; and how well the application addresses each of the selection criteria. The page limit also applies to any attachments to the project narrative other than the references/bibliography. In other words, the entirety of Part 3 of the application, including the aforementioned discussion and any attachments to the project narrative, must be limited to the equivalent of no more than 65 pages. The only allowable attachments other than those included in the project narrative are those outlined as “Other Attachments Forms” for Part 6 in the application package. Any attachments other than those included within the page limit of the project narrative and those outlined for Part 6 will not be reviewed.

The 65-page limit, or its equivalent, does not apply to the following sections of an application: Part 1 (including the response regarding research activities involving human subjects); Part 2 (two-page project abstract); Part 4 (the budget sections, including the chart and narrative budget justification); Part 5 (standard assurances and certifications); and Part 6 (other attachments forms, including, if applicable, references/bibliography for the project narrative; individual résumés for project director(s) and key personnel—applicants are encouraged to limit each résumé to no more than five pages; memoranda of understanding or other binding agreement; assurance regarding management partner; copy of applicant's indirect cost rate agreement; and letters of commitment and support from collaborating SEAs and organizations).

Our reviewers will not read any pages of your project narrative that exceed the page limit; or exceed the equivalent of the page limit if you apply other standards. Applicants are encouraged to submit applications that meet the page limit following the standards outlined in this section rather than submitting applications that are the equivalent of the page limit applying other standards.

3.Submission Dates and Times:

Applications Available:April 30, 2012.

Deadline for Notice of Intent to Apply:May 30, 2012.

We will be able to develop a more efficient process for reviewing grant applications if we have a better understanding of the number of applicants that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant to notify us of the applicant's intent to submit an application for funding by sending a short email message. This short email should provide the applicant organization's name and address. The Secretary requests that this email be sent toCollette.Roney@ed.govwith “Intent to Apply” in the email subject line. Applicants that do not provide this email notification may still apply for funding.

Deadline for Transmittal of Applications:June 14, 2012.

Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). Note that applications for this EAG ELP Competition must be submitted under CFDA number 84.368A-1; only applications for the EAG Accessibility Competition should be submitted under CFDA number 84.368A-2. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 7.Other Submission Requirementsof this notice.

We do not consider an application that does not comply with the deadline requirements.

Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed underFOR FURTHER INFORMATION CONTACTin section VII of this notice. If the Department provides an accommodation or auxiliary aid to anindividual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

Deadline for Intergovernmental Review: August 13, 2012.

4.Intergovernmental Review:This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

6.Data Universal Numbering System Number, Taxpayer Identification Number, and Central Contractor Registry:To do business with the Department of Education, you must—

a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database;

c. Provide your DUNS number and TIN on your application; and

d. Maintain an active CCR registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one business day.

If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2-5 weeks for your TIN to become active.

The CCR registration process may take five or more business days to complete. If you are currently registered with the CCR, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your CCR registration on an annual basis. This may take three or more business days to complete.

In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined in the Grants.gov Web page:www.grants.gov/applicants/get_registered.jsp.

7.Other Submission Requirements:Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

a.Electronic Submission of Applications.

Applications for grants under the Enhanced Assessment Instruments Grants Program ELP Competition, CFDA number 84.368A-1, must be submitted electronically using the Governmentwide Grants.gov Apply site atwww.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us. You should submit applications to this competition, the EAG ELP Competition, under CFDA number 84.368A-1; do not submit applications for this competition under CFDA number 84.368A-2, which is the number for the EAG Accessibility Competition.

We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirementandsubmit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section underException to Electronic Submission Requirement.

You may access the electronic grant application for the Enhanced Assessment Instruments Grants Program atwww.Grants.gov. You must search for the downloadable application package for this competition by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.368, not 84.368A).

Please note the following:

• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page atwww.G5.gov.

• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

• You must upload any narrative sections and all other attachments to your application as files in a .PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material.

• Your electronic application must comply with any page-limit requirements described in this notice.

• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.govtracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).

• We may request that you provide us original signatures on forms at a later date.

Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System:If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed underFOR FURTHER INFORMATION CONTACTin section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that that problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. The Department will contact you after a determination is made on whether your application will be accepted.

Note:

The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

Exception to Electronic Submission Requirement:You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because—

• You do not have access to the Internet; or

• You do not have the capacity to upload large documents to the Grants.gov system;

and

• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevent you from using the Internet to submit your application.

If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

b.Submission of Paper Applications by Mail.

If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address:U.S. Department of Education,Application Control Center,Attention: (CFDA Number 84.368A-1),LBJ Basement Level 1,400 Maryland Avenue SW.,Washington, DC 20202-4260.

You must show proof of mailing consisting of one of the following:

(1) A legibly dated U.S. Postal Service postmark.

(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

(3) A dated shipping label, invoice, or receipt from a commercial carrier.

(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

(1) A private metered postmark.

(2) A mail receipt that is not dated by the U.S. Postal Service.

If your application is postmarked after the application deadline date, we will not consider your application.

Note:

The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

c.Submission of Paper Applications by Hand Delivery.

If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address:U.S. Department of Education,Application Control Center,Attention: (CFDA Number 84.368A-1),550 12th Street SW.,Room 7041, Potomac Center Plaza,Washington, DC 20202-4260.

(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

V. Application Review Information

1.Selection Criteria:The selection criteria for this competition are from the notice of final priorities, requirements, definitions, and selection criteria published in theFederal Registeron April 19, 2011 (76 FR 21986) and are listed in the application package.

2.Review and Selection Process:We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may alsoconsider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

3.Special Conditions:Under 34 CFR 74.14 and 80.12, the Secretary may impose special conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 34 CFR parts 74 or 80, as applicable; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

VI. Award Administration Information

1.Award Notices:If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN). We may notify you informally, also.

If your application is not evaluated or not selected for funding, we notify you.

2.Administrative and National Policy Requirements:We identify administrative and national policy requirements in the application package and reference these and other requirements in theApplicable Regulationssection of this notice.

We reference the regulations outlining the terms and conditions of an award in theApplicable Regulationssection of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

3.Reporting:(a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c).

4.Performance Measures:Under the Government Performance and Results Act of 1993 (GPRA), the Department has developed four measures to evaluate the overall effectiveness of the Enhanced Assessment Instruments Grants program: (1) The number of States that participate in Enhanced Assessment Instruments Grants projects funded by this competition; (2) the percentage of grantees that, at least twice during the period of their grants, make available to SEA staff in non-participating States and to assessment researchers information on findings resulting from the Enhanced Assessment Instruments Grants through presentations at national conferences, publications in refereed journals, or other products disseminated to the assessment community; (3) for each grant cycle and as determined by an expert panel, the percentage of Enhanced Assessment Instruments Grants that yield significant research, methodologies, products, or tools regarding assessment systems or assessments; and (4) for each grant cycle and as determined by an expert panel, the percentage of Enhanced Assessment Instruments Grants that yield significant research, methodologies, products, or tools specifically regarding accommodations and alternate assessments for students with disabilities and limited English proficient students. Grantees will be expected to include in their interim and final performance reports information about the accomplishments of their projects because the Department will need data on these measures.

If you use a TDD or a TTY, call the FRS, toll-free, at 1-800-877-8339.

VIII. Other Information

Accessible Format:Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed underFOR FURTHER INFORMATION CONTACTin section VII in this notice.

Electronic Access to This Document:The official version of this document is the document published in theFederal Register. Free Internet access to the official edition of theFederal Registerand the Code of Federal Regulations is available via the Federal Digital System at:www.gpo.gov/fdsys.At this site you can view this document, as well as all other documents of this Department published in theFederal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in theFederal Registerby using the article search feature at:www.federalregister.gov.Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Purpose of Program:The purpose of the Enhanced Assessments Instruments Grants program, also called the Enhanced Assessment Grants (EAG) program, is to enhance the quality of assessment instruments and systems used by States for measuring theacademic achievement of elementary and secondary school students.

In 2012, the Department is holding two separate competitions for FY 2011 EAG funds. The competition announced in this notice (EAG Accessibility Competition) (CFDA No. 84.368A-2) will support efforts designed to advance practice significantly in the area of increasing the accessibility and validity of assessments for students with disabilities or limited English proficiency, or both, including strategies for test design, administration with accommodations, scoring, and reporting. Elsewhere in this issue of theFederal Registerwe are publishing a notice inviting applications for a separate competition for FY 2011 EAG funds to be awarded in 2012 (the EAG English Language Proficiency (ELP) Competition, CFDA No. 84.368A-1). The Department may use any unused funds from the competition announced in this notice to make awards in the EAG ELP Competition. Conversely, the Department may use any unused funds from the EAG ELP Competition to make awards in the competition announced in this notice.

Priorities:This competition includes four absolute priorities and three competitive preference priorities. In accordance with 34 CFR 75.105(b)(2)(iv), absolute priorities 1 through 4 (Statutory Priorities) are based on section 6112 of the Elementary and Secondary Education Act of 1965, as amended (ESEA) (20 U.S.C. 7301a). Competitive Preference Priority 1 and Competitive Preference Priority 3 are from Appendix E to the notice of final requirements for optional State consolidated applications submitted under section 9302 of the ESEA, published in theFederal Registeron May 22, 2002 (67 FR 35967). Competitive Preference Priority 2 is from the notice of final priorities, requirements, definitions, and selection criteria, published in theFederal Registeron April 19, 2011 (76 FR 21986).

Absolute Priorities:For awards made from this competition in 2012 with FY 2011 funds, and any subsequent year in which we make awards from the list of unfunded applicants from this competition, these priorities are absolute priorities. Under 34 CFR 75.105(c)(3) we consider only applications that meet one or more of the Statutory Priorities.

These priorities are:

Absolute Priority 1—Collaboration.Collaborate with institutions of higher education, other research institutions, or other organizations to improve the quality, validity, and reliability of State academic assessments beyond the requirements for these assessments described in section 1111(b)(3) of the ESEA.

Competitive Preference Priorities:For awards made in 2012 with FY 2011 funds, and any subsequent year in which we make awards from the list of unfunded applicants from this competition, the following priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i) we award up to an additional 25 points to an application, depending on how well the application meets these competitive preference priorities.

These priorities are:

Competitive Preference Priority 1—Accommodations and Alternate Assessments (up to 15 points).Applications that can be expected to advance practice significantly in the area of increasing accessibility and validity of assessments for students with disabilities or limited English proficiency, or both, including strategies for test design, administration with accommodations, scoring, and reporting.

(b) Identify in its application a proposed project management partner and provide an assurance that the proposed project management partner is not partnered with any other eligible applicant applying for an award under this competition1;

1In selecting a proposed project management partner, an eligible applicant must comply with the requirements for procurement in 34 CFR 80.36.

(c) Provide a description of the consortium's structure and operation. The description must include—

(1) The organizational structure of the consortium (e.g., differentiated roles that a member State may hold);

(2) The consortium's method and process (e.g., consensus, majority) for making different types of decisions (e.g., policy, operational);

(3) The protocols by which the consortium will operate, including protocols for member States to change roles in the consortium, for member States to leave the consortium, and for new member States to join the consortium;

(4) The consortium's plan, including the process and timeline, for setting key policies and definitions for implementing the proposed project, including, for any assessments developed through a project funded by this grant, the common set of standards upon which to base the assessments, a common set of performance-level descriptors, a common set of achievement standards, common assessment administration procedures, common item-release and test-security policies, and a common set of policies and procedures for accommodations and student participation; and

(5) The consortium's plan for managing grant funds received under this competition; and

(d) Provide a memorandum of understanding or other binding agreement executed by each State in the consortium that includes an assurance that, to remain in the consortium, the State will adopt or use any instrument, including to the extent applicable, assessments, developed under the proposed project no later than the end of the project period.

Competitive Preference Priority 3—Dissemination (5 points).Applications that include an effective plan for dissemination of results.

Requirements:The following requirement, which was published in theFederal Registeron April 19, 2011 (76 FR 21986), applies to this competition. An eligible applicant awarded a grant under this program must:

Unless otherwise protected by law or agreement as proprietary information, make any assessment content (i.e., assessments and assessment items) and other assessment-related instruments developed with funds from this competition freely available to States, technology platform providers, and others that request it for purposes of administering assessments, provided that those parties receiving assessment content comply with consortium or State requirements for test or item security.

Definitions:The following definition, which was published in theFederal Registeron April 19, 2011 (76 FR 21986), applies to this competition.

Student with a disabilitymeans a student who has been identified as a child with a disability under the Individuals with Disabilities Education Act, as amended.

Program Authority:20 U.S.C. 7301a and 7842.

Applicable Regulations:(a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 74, 75, 77, 80, 81, 82, 84, 86, 97, 98, and 99. (b) The Debarment and Suspension regulations in 2 CFR part 3485. (c) The notice of final requirements for optional State consolidated applications submitted under section 9302 of the ESEA, published in theFederal Registeron May 22, 2002 (67 FR 35967). (d) The notice of final priorities, requirements, definitions, and selection criteria, published in theFederal Registeron April 19, 2011 (76 FR 21986). (e) The notice of final revision to selection criteria, published elsewhere in this issue of theFederal Register.

Note:

The regulations in 34 CFR part 86 apply to institutions of higher education only.

II. Award Information

Type of Award:Discretionary grants.

Estimated Available Funds:$3,900,000 in FY 2011 funds to be awarded in 2012. Contingent upon the availability of funds and the quality of applications, we may make additional awards with FY 2012 funds from the list of unfunded applicants from this competition.

Estimated Range of Awards:$1,000,000 to $3,000,000.

Estimated Average Size of Awards:$1,950,000.

Estimated Number of Awards:2.

Note:

Applicants should submit a single budget request for a single budget and project period of up to 24 months. Subject to the availability of future years' funds, the Department may make supplemental grant awards to the grants awarded with FY 2011 funds.

Note:

The Department is not bound by any estimates in this notice.

Project Period:Up to 24 months.

III. Eligibility Information

1.Eligible Applicants:State educational agencies (SEAs) as defined in section 9101(41) of the ESEA and consortia of such SEAs.

2.Cost Sharing or Matching:This competition does not require cost sharing or matching.

3.Other:An application from a consortium of SEAs must designate one SEA as the fiscal agent.

IV. Application and Submission Information

1.Address to Request Application Package:You can access the electronic grant application for the Enhanced Assessment Instruments Grants Program atwww.Grants.gov.You must search for the downloadable application package for this competition by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.368, not 84.368A). Your search will result in two grant opportunities; be sure to select the opportunity for the EAG Accessibility Competition application package. You can also obtain a copy of the application package by contacting the program contact persons listed underAgency Contactsin section VII of this notice.

Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the person listed underAccessible Formatin section VIII of this notice.

2.Content and Form of Application Submission:Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this competition.

Page Limit:The application narrative (Part 4 of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application and the absolute and competitive preference priorities. You must limit the application narrative (Part IV) to the equivalent of no more than 45 pages, using the following standards:

• A “page” is 8.5″ x 11″, on one side only with 1″ margins at the top, bottom, and both sides.

• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.

• Times New Roman font no smaller than 11.0 point for all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs. (Font sizes that round up to 11, such as 10.7 point, will be considered as smaller than 11.0.)

• Any screen shots included as part of the application narrative should follow these standards or, if other standards are applied, be sized to equal the equivalent amount of space if these standards were applied.

The page limit does not apply to: Part 1 (including the response regarding research activities involving human subjects); Parts 2 and 5 (the budget sections, including the chart and narrative budget justification); Part 3 (one-page project abstract); Part 6 (other attachments forms, including, if applicable, references/bibliography for the application narrative; résumés for the project director and key personnel—applicants are encouraged to limit each résumé to no more than five pages; memoranda of understanding or other binding agreement; assurance regarding management partner; copy of indirect cost rate agreement; and letters of commit and support); and Part 7 (the assurances and certifications, including the General Education Provisions Act 427 response).

The page limit applies to Part 4 project narrative, including any table of contents for it. This section must include a discussion of how the application meets at least one of the absolute priorities, how well the application meets the competitive preference priorities (if applicable), and how well the application addresses each of the selection criteria. The page limit also applies to any attachments to the project narrative other than references/bibliography. In other words, the entirety of Part 4 of the application, including the discussion described in this paragraph and any attachments to the narrative, must be limited to the equivalent of no more than 45 pages. The only allowable attachments other than any included in the project narrative are those described in Part 6. Any attachments other than those included within the page limit of the project narrative and those outlined for Part 6 will not be reviewed.

Our reviewers will not read any pages of your project narrative that exceed the page limit or that exceed the equivalent of the page limit if you apply other standards. Applicants are encouraged to submit applications that meet the page limit following the standards outlined in this section rather than submitting applications that are the equivalent of the page limit applying other standards.

3.Submission Dates and Times:

Applications Available:April 30, 2012.

Deadline for Notice of Intent to Apply:May 30, 2012.

We will be able to develop a more efficient process for reviewing grant applications if we have a better understanding of the number of applicants that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant tonotify us of the applicant's intent to submit an application for funding by sending a short email message. This short email should provide the applicant organization's name and address. The Secretary requests that this email be sent toCollette.Roney@ed.govwith “Intent to Apply” in the email subject line. Applicants that do not provide this email notification may still apply for funding.

Deadline for Transmittal of Applications:June 14, 2012.

Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). Note that applications for this EAG Accessibility Competition must be submitted under CFDA number 84.368A-2; only applications for the EAG ELP Competition should be submitted under CFDA number 84.368A-1. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 7.Other Submission Requirementsof this notice.

We do not consider an application that does not comply with the deadline requirements.

Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed underFOR FURTHER INFORMATION CONTACTin section VII of this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

Deadline for Intergovernmental Review:August 13, 2012.

4.Intergovernmental Review:This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

6.Data Universal Numbering System Number, Taxpayer Identification Number, and Central Contractor Registry:To do business with the Department of Education, you must—

a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR), the Government's primary registrant database;

c. Provide your DUNS number and TIN on your application; and

d. Maintain an active CCR registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one business day.

If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2-5 weeks for your TIN to become active.

The CCR registration process may take five or more business days to complete. If you are currently registered with the CCR, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your CCR registration on an annual basis. This may take three or more business days to complete.

In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined in the Grants.gov Web page:www.grants.gov/applicants/get_registered.jsp.

7.Other Submission Requirements:Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

a.Electronic Submission of Applications.

Applications for grants under the Enhanced Assessment Instruments Grants Program, CFDA number 84.368A-2, must be submitted electronically using the Governmentwide Grants.gov Apply site atwww.Grants.gov.Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us. You should submit applications to this competition, the EAG Accessibility Competition, under CFDA number 84.368A-2; do not submit applications for this competition under CFDA number 84.368A-1, which is the number for the EAG ELP Competition.

We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirementandsubmit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section underException to Electronic Submission Requirement.

You may access the electronic grant application for the Enhanced Assessment Instruments Grants Program atwww.Grants.gov.You must search for the downloadable application package for this competition by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.368, not 84.368A).

Please note the following:

• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

• You should review and follow the Education Submission Procedures for submitting an application throughGrants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page atwww.G5.gov.

• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

• You must upload any narrative sections and all other attachments to your application as files in a PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material.

• Your electronic application must comply with any page-limit requirements described in this notice.

• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).

• We may request that you provide us original signatures on forms at a later date.

Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System:If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed underFOR FURTHER INFORMATION CONTACTin section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that that problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. The Department will contact you after a determination is made on whether your application will be accepted.

Note:

The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

Exception to Electronic Submission Requirement:You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because—

• You do not have access to the Internet; or

• You do not have the capacity to upload large documents to the Grants.gov system;

and

• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevent you from using the Internet to submit your application.

If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

b.Submission of Paper Applications by Mail.

If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.368A-2), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

You must show proof of mailing consisting of one of the following:

(1) A legibly dated U.S. Postal Service postmark.

(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

(3) A dated shipping label, invoice, or receipt from a commercial carrier.

(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

(1) A private metered postmark.

(2) A mail receipt that is not dated by the U.S. Postal Service.

If your application is postmarked after the application deadline date, we will not consider your application.

Note:

The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

c.Submission of Paper Applications by Hand Delivery.

If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention:(CFDA Number 84.368A-2), 550 12th Street SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260.

Note for Mail or Hand Delivery of Paper Applications:If you mail or hand deliver your application to the Department—

(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

V. Application Review Information

1.Selection Criteria:The selection criteria for this competition are from the notice of final priorities, requirements, definitions, and selection criteria, published elsewhere in this issue of theFederal Registerand are listed in the application package.

2.Review and Selection Process:We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

3.Special Conditions:Under 34 CFR 74.14 and 80.12, the Secretary may impose special conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 34 CFR parts 74 or 80, as applicable; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

VI. Award Administration Information

1.Award Notices:If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN). We may notify you informally, also.

If your application is not evaluated or not selected for funding, we notify you.

2.Administrative and National Policy Requirements:We identify administrative and national policy requirements in the application package and reference these and other requirements in theApplicable Regulationssection of this notice.

We reference the regulations outlining the terms and conditions of an award in theApplicable Regulationssection of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

3.Reporting:(a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c).

4.Performance Measures:Under the Government Performance and Results Act of 1993 (GPRA), the Department has developed four measures to evaluate the overall effectiveness of the Enhanced Assessment Instruments Grants program: (1) The number of States that participate in Enhanced Assessment Instruments Grants projects funded by this competition; (2) the percentage of grantees that, at least twice during the period of their grants, make available to SEA staff in non-participating States and to assessment researchers information on findings resulting from the Enhanced Assessment Instruments Grants through presentations at national conferences, publications in refereed journals, or other products disseminated to the assessment community; (3) for each grant cycle and as determined by an expert panel, the percentage of Enhanced Assessment Instruments Grants that yield significant research, methodologies, products, or tools regarding assessment systems or assessments; and (4) for each grant cycle and as determined by an expert panel, the percentage of Enhanced Assessment Instruments Grants that yield significant research, methodologies, products, or tools specifically regarding accommodations and alternate assessments for students with disabilities and limited English proficient students. Grantees will be expected to include in their interim and final performance reports information about the accomplishments of their projects because the Department will need data on these measures.

Accessible Format:Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed underFOR FURTHER INFORMATION CONTACTin section VII in this notice.

Electronic Access to This Document:The official version of this document is the document published in theFederal Register. Free Internet access to the official edition of theFederal Registerand the Code of Federal Regulations is available via the Federal Digital System at:www.gpo.gov/fdsys.At this site you can view this document, as well as all other documents of this Department published in theFederal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in theFederal Registerby using the article search feature at:www.federalregister.gov.Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

On March 27, 2012, the Office of Innovation and Improvement in the U.S. Department of Education published in theFederal Register(77 FR 18216) a notice inviting applications for new awards for fiscal year 2012 for the Investing in Innovation (i3) Scale-up grant competition (March 27 i3 Scale-up NIA). This notice extends the deadline date and date for intergovernmental review announced in, and corrects an error in, the March 27 i3 Scale-up NIA.

DATES:

Deadline for Transmittal of Applications:May 30, 2012.

Deadline for Intergovernmental Review:July 26, 2012.

SUPPLEMENTARY INFORMATION:Deadline Date Extension

In the March 27 i3 Scale-up NIA the Department announced the 2012 i3 Scale-up grant competition and indicated that the Deadline for Transmittal of Applications was May 29, 2012. Applicants under this competition are required to use Grants.gov. Since publishing the March 27 i3 Scale-up NIA, it has come to the Department's attention that the Grants.gov help desk will be closed in observance of Memorial Day on Monday, May 28—the day before the original Deadline for the Transmittal of Applications that was announced in the March 27 i3 Scale-up NIA. The Department extends the deadline date for this competition to May 30, 2012 so that applicants will have sufficient access to the Grants.gov help desk to address any technical issues related to the application submission that may arise the day before the deadline date. As a result of the change in the deadline date, we are also extending the Date for Intergovernmental Review by one day—to July 26, 2012.

Correction

An error appears in theElectronic Submission of Applicationssection of the March 27 i3 Scale-up NIA. In seven places within that section, the notice indicates that applications must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30 p.m., Washington, DC time, on the application deadline date. These references to “4:30 p.m.” should be references to “4:30:00 p.m.” For this reason, we correct the March 27 i3 Scale-up NIA as follows:

On page 18225, second column, second bulleted paragraph, correct the three references to “4:30 p.m.” to read “4:30:00 p.m.”.

On page 18225, third column, last paragraph, correct the reference to “4:30 p.m.” to read “4:30:00 p.m.”.

On page 18226, first column, first full paragraph, correct the two references to “4:30 p.m.” to read “4:30:00 p.m.”.

On page 18226, second column, last paragraph, correct the reference to “4:30 p.m.” to read “4:30:00 p.m.”.

Program Authority:

American Recovery and Reinvestment Act of 2009, Division A, Section 14007, Public Law 111-5.

If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

Accessible Format:Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g.,braille, large print, audiotape, or compact disc) on request to the program contact person listed underFOR FURTHER INFORMATION CONTACTin this notice.

Electronic Access to This Document:The official version of this document is the document published in theFederal Register. Free Internet access to the official edition of theFederal Registerand the Code of Federal Regulations is available via the Federal Digital System at:www.gpo.gov/fdsys.At this site you can view this document, as well as all other documents of this Department published in theFederal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in theFederal Registerby using the article search feature at:www.federalregister.gov.Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

On March 27, 2012, the Office of Innovation and Improvement in the U.S. Department of Education published in theFederal Register(77 FR 18229) a notice inviting applications for new awards for fiscal year 2012 for the Investing in Innovation (i3) Validation grant competition (March 27 i3 Validation NIA). This notice extends the deadline date and date for intergovernmental review announced in, and corrects an error in the March 27 i3 Validation NIA.

DATES:

Deadline for Transmittal of Applications:May 30, 2012.

Deadline for Intergovernmental Review:July 26, 2012.

SUPPLEMENTARY INFORMATION:Deadline Date Extension

In the March 27 i3 Validation NIA the Department announced the 2012 i3 Validation grant competition and indicated that the Deadline for Transmittal of Applications was May 29, 2012. Applicants under this competition are required to use Grants.gov. Since publishing the March 27 i3 Validation NIA, it has come to the Department's attention that the Grants.gov help desk will be closed in observance of Memorial Day on Monday, May 28—the day before the original Deadline for the Transmittal of Applications that was announced in the March 27 i3 Validation NIA. The Department extends the deadline date for this competition to May 30, 2012 so that applicants will have sufficientaccess to the Grants.gov help desk to address any technical issues related to application submission that may arise the day before the deadline date. As a result of the change in the deadline date, we are also extending the Date for Intergovernmental Review by one day—to July 26, 2012.

Correction

An error appears in theElectronic Submission of Applicationssection of the March 27 i3 Validation NIA. In seven places within that section, the notice indicates that applications must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30 p.m., Washington, DC time, on the application deadline date. These references to “4:30 p.m.” should be references to “4:30:00 p.m.” For this reason, we correct the March 27 i3 Validation NIA as follows:

On page 18238, second column, second bulleted paragraph, correct the three references to “4:30 p.m.” to read “4:30:00 p.m.”.

If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

Accessible Format:Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed underFOR FURTHER INFORMATION CONTACTin this notice.

Electronic Access to This Document:The official version of this document is the document published in theFederal Register. Free Internet access to the official edition of theFederal Registerand the Code of Federal Regulations is available via the Federal Digital System at:www.gpo.gov/fdsys.At this site you can view this document, as well as all other documents of this Department published in theFederal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in theFederal Registerby using the article search feature at:www.federalregister.gov.Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Office of Elementary and Secondary Education, Department of Education.

ACTION:

Notice.

SUMMARY:

The Assistant Secretary for Elementary and Secondary Education amends the selection criteria under the Enhanced Assessment Instruments Grant program, also called the Enhanced Assessment Grant (EAG) program, as established in the notice of final priorities, requirements, definitions, and selection criteria published in theFederal Registeron April 19, 2011 (2011 NFP). The 2011 NFP established specific priorities, requirements, definitions, and selection criteria that may be used for the EAG program. The revisions in this notice provide the Secretary with additional flexibility with respect to selection criteria for EAG competitions in 2012 that use fiscal year (FY) 2011 funds and for subsequent competitions. We believe that these revisions will enable the Department to administer this program more effectively, simplify the application and review processes, and better ensure that the strongest applications receive EAG funds.

If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service, toll free, at 1-800-877-8339.

SUPPLEMENTARY INFORMATION:

Purpose of Program:The purpose of the EAG program is to enhance the quality of assessment instruments and systems used by States for measuring the academic achievement of elementary and secondary school students.

Program Authority:20 U.S.C. 7301a.

We published a notice of proposed revisions for this program in theFederal Registeron January 30, 2012 (77 FR 4553). That notice contained background information and our reasons for proposing the revisions relating to the use of selection criteria for this program.

Public Comment:In response to our invitation in the notice of proposed revisions, we did not receive any comments. However, as a result of our further review of the proposed revisions since publication of the notice of proposed revisions, we have made one change as follows:

Analysis of Comments and Changes

Comment:None.

Discussion:In reviewing the statement of the proposed revisions to selection criteria further, the Department has decided that it may be helpful to address the assignment of maximum possible points—not only with respect to criteria used for competitions, but also with respect to factors under those criteria. The Department has the authority under 34 CFR 75.201 to assign maximum points at the factor level. This change, therefore, does not substantively change the Department's authority or practice; it merely describes the manner in which the Department may indicate whether factors under a selection criterion have been assigned maximum points.

Changes:We have added language to the statement of revisions to clarify that the Department may assign, in the notice inviting applications, the application package, or both, the maximum possible points an applicant may earn under each factor under a selection criterion.

Final Revisions to Selection Criteria

The Secretary may use one or more of the selection criteria listed in paragraphs (a) through (d) for evaluating an application under this program. This flexibility includes the authority to reduce the number of selection criteria. In order to assist peer reviewers indetermining the degree to which an applicant meets a criterion, the Secretary may further define each criterion from each of these sources by selecting one or more specific factors within a criterion or assigning factors from one criterion, from any of those sources, to another criterion, in any of those sources. We may apply one or more of these criteria in any year in which this program is in effect. In the notice inviting applications or the application package, or both, we will announce the maximum possible points assigned to each criterion and may also assign the maximum possible points for each factor.

Selection criteria for any EAG competition may come from:

(a) The selection criteria established in the 2011 NFP.

(b) The selection criteria in 34 CFR 75.210.

(c) Selection criteria based on the statutory requirements for the EAG program in accordance with 34 CFR 75.209.

(d) Any combination of selection criteria and factors in paragraphs (a) through (c).

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Note:

This notice does not solicit applications. In any year in which we choose to use one or more of these selection criteria, we invite applications through a notice in theFederal Register.1

1Availability of funds for the EAG program for a given year is contingent upon an appropriation of funds for the program by the Congress.

Executive Orders 12866 and 13563

Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are taking this regulatory action only on a reasoned determination that its benefits justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that these regulations are consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits of this regulatory action. The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

Summary of Potential Costs and Benefits

This regulatory action affects only State educational agencies (SEAs) or consortia of SEAs applying for assistance under the EAG program. It creates flexibility for the Department, with respect to EAG competitions in 2012 for FY 2011 funds and for subsequent competitions, to select from among, or to combine, selection criteria that were established in the 2011 NFP criteria, selection criteria from 34 CFR 75.210, and other selection criteria based on the statute under 34 CFR 75.209. This flexibility allows the Department to align selection criteria with program needs and ensure that the strongest applications are selected for funding under the program.

This flexibility does not impose a financial burden that SEAs would not otherwise incur in the development and submission of a grant application under the EAG program. In addition, under some circumstances (for example, if the Department elected to use fewer criteria or factors in a given competition), the revisions could reduce the financial burden of preparing an EAG grant application by a modest amount. Moreover, the Department typically only receives a small number of applications for this program, which further serves to mitigate any potential costs because few entities are affected.

Intergovernmental Review:This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

Accessible Format:Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or computer diskette) on request to the program contact person listed underFOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document:The official version of this document is the document published in theFederal Register.Free Internet access to the official edition of theFederal Registerand the Code of Federal Regulations is available via the Federal Digital System at:www.gpo.gov/fdsys.At this site you can view this document, as well as all other documents of this Department published in theFederal Register,in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in theFederal Registerby using the article search feature at:www.federalregister.gov.Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Dated: April 25, 2012.Michael Yudin,Acting Assistant Secretary for Elementary and Secondary Education.[FR Doc. 2012-10357 Filed 4-27-12; 8:45 am]BILLING CODE 4000-01-PDEPARTMENT OF ENERGYAmended Notice of Intent To Modify the Scope of the Environmental Impact Statement for the Champlain Hudson Power Express Transmission Line Project in New York StateAGENCY:

Department of Energy.

ACTION:

Amended Notice of Intent.

SUMMARY:

The United States (U.S.) Department of Energy (DOE) intends to modify the scope of theChamplain Hudson Power Express Transmission Line Project Environmental Impact Statement(CHPE EIS; DOE/EIS-0447) and to conduct additional public scoping. As described in the original Notice of Intent (NOI) (75 FR 34720; June 18, 2010), in January 2010, Transmission Developers Inc. (TDI) submitted, on behalf of Champlain Hudson Power Express, Inc. (Applicant), an application to DOE for a Presidential permit for the Champlain Hudson Power Express (Champlain Hudson) project. As explained in the NOI, DOE will assess the potential environmental impacts associated with the construction, operation, maintenance, and connection of the proposed new electric transmission line across the U.S.-Canada border in northeastern New York State. Public scoping originally closed on August 2, 2010. On February 28, 2012, TDI submitted an amendment to the application for a Presidential permit to DOE that reflects proposed changes to the route of the Champlain Hudson project, and DOE now intends to revise the scope of the EIS to address these proposed changes. The proposed changes are the result of settlement negotiations among New York (NY) State agencies, Champlain Hudson Power Express, Inc., CHPE Properties, Inc. and other stakeholders as part of the project review under Article VII of the New York State Public Service Law, and are reflected in a February 24, 2012, “Joint Proposal” submitted to the New York Public Service Commission.

The U.S. Fish & Wildlife Service, New York Field Office (USFWS Region 5), the U.S. Army Corps of Engineers (USACE), the U.S. Environmental Protection Agency (EPA Region 2), the New York State Department of Environmental Conservation (NYSDEC), and the New York State Department of Public Service (NYSDPS) are cooperating agencies in the preparation of the EIS.

DATES:

DOE is accepting public comments on the revised scope of the CHPE EIS until June 14, 2012. DOE will consider comments submitted after this date to the extent practicable.

ADDRESSES:

Please direct written comments on the scope of the EIS and requests to be added to the document mailing list to: Brian Mills, Office of Electricity Delivery and Energy Reliability (OE-20), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585; by electronic mail toBrian.Mills@hq.doe.gov;or by facsimile to 202-586-8008. For general information on the DOE NEPA process contact: Ms. Carol M. Borgstrom, Director, Office of NEPA Policy and Compliance (GC-54), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585; telephone 202-586-4600, or leave a message at 1-800-472-2756; by facsimile at 202-586-7031; or send an email toaskNEPA@hq.doe.gov.

For information on the USFWS's role as a cooperating agency, contact Tim R. Sullivan by electronic mail atTim_R_Sullivan@fws.gov;by phone at 602-753-9334; or by mail at 3817 Luker Road, Cortland, NY 13045.

For information on the EPA's role as a cooperating agency, contact Lingard Knutson by electronic mail atKnutson.Lingard@epamail.epa.gov;by phone at 212-637-3747; or by mail at 290 Broadway, Mail Code: 25th Floor, New York, NY 10007-1866.

For information on the New York State Department of Environmental Conservation's role as a cooperating agency, contact Patricia Desnoyers by electronic mail topjdesnoy@gw.dec.state.ny.us;or by mail at 625 Broadway, Albany, NY 12233.

For information on the New York State Department of Public Service's role as a cooperating agency, contact James Austin by electronic mail atjames_austin@dps.state.ny.us;or by mail at 3 Empire State Plaza, Albany, NY 12223.

SUPPLEMENTARY INFORMATION:Background

Executive Order (E.O.) 10485, Providing for the performance of certain functions heretofore performed by the President with respect to electric power and natural gas facilities located on the borders of the United States,as amended by E.O. 12038Relating to certain Functions transferred to the Secretary of Energy by the Department of Energy Organization Act,requires issuance of a Presidential permit by DOE before electric transmission facilities may be constructed, operated, maintained, or connected at the U.S. international border. The E.O. provides that a Presidential permit may be issued after a finding that the proposed project is consistent with the public interest and after favorable recommendations from the U.S. Departments of State and Defense. In determining consistency with the public interest, DOE considers the potential environmental impacts of the proposed project under NEPA, determines the project's impact on electric reliability (including whether the proposed project would adversely affect the operation of the U.S. electric power supply system under normal and contingency conditions), and considers any other factors that DOE may find relevant to the public interest. The regulations implementing the E.O. have been codified at 10 CFR 205.320-205.329. DOE's issuance of a Presidential permit would indicate that there is no Federal objection to the project, but would not mandate that the project be constructed.

On January 25, 2010, TDI submitted an application, on behalf of ChamplainHudson Power Express, Inc., to DOE's Office of Electricity Delivery and Energy Reliability for a Presidential permit to construct, operate, maintain, and connect a 2,000-megawatt (MW) high-voltage direct current (HVDC) Voltage Source Converter (VSC) controllable transmission system from the Canadian Province of Quebec to the New York City and southwestern Connecticut regions. After due consideration of the nature and extent of the proposed project, including evaluation of the “Information Regarding Potential Environmental Impacts” section of the Presidential permit application, DOE determined that the appropriate level of NEPA review for this project is an EIS. DOE issued its original NOI for this EIS on June 18, 2010 (75 FR 34720).

On August 5, 2010, TDI submitted an amendment to the application that eliminated a portion of the proposed transmission line consisting of a bipole (two cables) that would have extended into Connecticut (the Connecticut Circuit). This change in the project's design resulted in a proposed HVDC transmission line that would consist of a bipole with a capacity of 1,000-MW. The amendment also proposed extending the route using existing railroad easements to Whitehall, NY, and connecting to the Consolidated Edison (Con Edison) system at a new substation in Astoria, Queens, NY. On July 7, 2011, TDI submitted an amendment to the application that addressed five conditions required by the New York State Department of State (NYSDOS). A copy of these amendments can be found athttp://chpexpresseis.org.

On February 28, 2012, TDI submitted another amendment to the Champlain Hudson project Presidential permit application to reflect changes to the proposed route that resulted from a project review process under Article VII of the New York State Public Service Law. A copy of the February 28, 2012, permit application amendment letter and other project-related documents can be viewed athttp://chpexpresseis.org.

New York State Certification Review Process

Article VII of the New York State Public Service Law establishes the review process for consideration of any application to construct and operate a major electric transmission system. As part of this process, the New York State Public Service Commission (Commission) received the application for a Certificate of Environmental Compatibility and Public Need from Champlain Hudson Power Express, Inc. in a series of documents dated March 29, 2010, and held public statement hearings on the original application in 2010.

Subsequently, the Applicant entered into settlement negotiations with several parties regarding the proposed facility need and benefits, alternate locations, environmental impacts, and mitigation measures. These negotiations resulted in a “Joint Proposal” which includes a proposed project alignment and configuration that is different from the original proposal for the Champlain Hudson project. The Joint Proposal also contains provisions regarding construction methods, environmental controls and mitigation measures, including the creation of a trust to study and mitigate possible impacts of the Champlain Hudson project's underwater cables on habitat in the Hudson River Estuary, the Harlem and East Rivers, Lake Champlain, and their tributaries. A copy of the Joint Proposal and other related documents can be viewed athttp://chpexpresseis.org.

Applicant's Proposal

As set forth in the Joint Proposal, the Applicant's preferred alternative now consists of a single 1,000-MW HVDC bipole. The bipole is comprised of two connected submarine or underground cables, one of which is positively charged, and the other negatively charged. In total, two cables would be laid between the Province of Quebec, Canada, and a proposed converter station in Astoria, Queens, NY. The converter station would change the electrical power from direct current to alternating current (AC). The converter station would be connected to the New York Power Authority gas insulated switchgear substation via an underground HVAC line, and the substation would be connected to Con Edison's Rainey Substation, located in Astoria, via HVAC cables installed under New York City streets. The proposed transmission line would connect renewable sources of power generation in Canada with load centers in and around New York City.

The Champlain Hudson project would still originate at an HVDC converter station near Hydro-Québec TransÉnergie's 765/315-kilovolt (kV) Hertel substation, located southeast of Montreal, and continue approximately 35 miles to the international border between the United States and Canada where the HVDC cables would originate underwater at the Town of Champlain, NY and extend south through Lake Champlain for approximately 101 miles, entirely within the jurisdictional waters of New York State. However, instead of exiting the southern end of Lake Champlain at the Village of Whitehall, NY, as originally proposed, the cables would now exit Lake Champlain at the Town of Dresden and run underground along New York State Route 22 to Whitehall.

The Upper Hudson River portion of the Hudson River polychlorinated biphenyl (PCB) site (USEPA Identification Number NYD980763841) stretches from Hudson Falls, NY, to the Federal Dam at Troy, NY. To avoid installing and burying HVDC cables within this area and in certain sensitive areas of the lower Hudson River, the cables would now be buried along an overland route. From Whitehall, the cables would transition from the Route 22 right-of-way (ROW) to enter the originally proposed route in existing railroad ROW owned by Canadian Pacific Railway (CP) and would remain buried for approximately 65 miles in and along the railroad ROW from Whitehall to Schenectady, NY. The proposed route would enter Erie Boulevard just north of the railroad crossing at Nott Street and continue along Erie Boulevard to a point south of State Street where it would again enter the railroad ROW. Along this portion of the route there are various alternative routings that include both the railroad ROW and public ways for transitioning from the railroad to city streets. The public ways include Nott Street, North Jay Street, Green Street, North Center Street, Pine Street, Union Street, Liberty Street and State Street as well as private property (a parking lot) located at approximately 160 Erie Boulevard. The route would follow the railroad ROW for a short distance, and would then deviate west of the railroad property, pass under Interstate 890 then turn south, running approximately parallel with the CSX Transportation (CSX) railroad ROW, and would re-enter the CP railroad ROW just north of Delaware Avenue.

From this point in Schenectady, the proposed route would follow the CP railroad ROW to the Town of Rotterdam, NY. In Rotterdam, the route would transfer from the CP railroad ROW to the CSX railroad ROW and would proceed southeast for approximately 24 miles before entering the Town of Selkirk, NY. The cables would then travel south for approximately 29 miles generally in and along CSX railroad ROW through the municipalities of Ravena, New Baltimore, Coxsackie, the Town of Athens, and the Town of Catskill, NY. As originally proposed the cables would have entered the Hudson River at the Town of Coeymans, NY. Now, the cables would enter the Hudson River at the Town of Catskill(hamlet of Cementon), via horizontal direction drilling (HDD). The HVDC underwater cables would be located within the Hudson River for approximately 67 miles until reaching a point north of Haverstraw Bay. As part of the revised project route, the cables would then exit the Hudson River at the Town of Stony Point in Rockland County, NY, to allow for a 7.7 mile bypass of Haverstraw Bay; this portion of the route would include three HDD installations under the Stony Point State Historic Park Site and Rockland Lake State Park. After the HDD under the parks, the cables would enter the Hudson River via HDD and be buried in the river for approximately 20.7 miles to the Spuyten Duyvil, where it would now extend south-easterly within the Harlem River for approximately 6.6 miles before exiting the water to a location along an existing railway ROW in the borough of the Bronx, NY. The cables would then continue along that ROW for approximately 1.1 miles.

At this point, the revised route would enter the East River via HDD, cross the East River and make land-fall at Astoria, Queens, NY. The cables would terminate at a new converter station proposed to be located near Luyster Creek, north of 20th Avenue, for a total length of approximately 330 miles from the U.S. border with Canada. The converter station would be installed on properties owned by Con Edison located in an industrial zone in Astoria and is proposed to have a total footprint of approximately five acres. The converter station would interconnect via underground circuit with the NYPA substation near the site of the Charles Poletti Power Project in Queens, NY. The substation would be connected to Con Edison's Rainey Substation, located in Astoria, via HVAC cables installed under New York City streets. A map of the proposed Champlain Hudson transmission line project route can be found athttp://chpexpresseis.org.

Previous Public Scoping

A public scoping period for the CHPE EIS began with the publication of DOE's NOI in theFederal Registeron June 18, 2010. The 45-day public scoping period closed on August 2, 2010. DOE received scoping comments in the form of 22 written letters or emails from private citizens, government agencies, and nongovernmental organizations. DOE held public scoping meetings from July 8, through July 16, 2010, in Bridgeport, Connecticut and Manhattan, Yonkers, Kingston, Albany, Queensbury, and Plattsburg, NY. A total of 33 people gave verbal comments at the meetings, and their comments were transcribed by court stenographers.

Commenters requested that the EIS establish evidence that the Champlain Hudson project is necessary to meet electricity demands (either current or future) in the project region, as well as address concerns over the impact of construction on existing transmission infrastructure. Commenters expressed concerns with regard to sediment disturbance and the potential impacts of contaminants in the water column on humans and wildlife from burying the transmission line in Lake Champlain and the Hudson River. Commenters also requested that the EIS specifically analyze potential thermal effects and effects of electromagnetic fields on aquatic ecosystems, and noted concern over impacts to visually important resources from construction of the transmission line. Commenters noted potential environmental and socioeconomic impacts from a proposed electric converter station in Yonkers, NY. Finally, commenters identified additional alternatives that they believed should be analyzed in the EIS. A copy of the Scoping Summary Report (December 2010) is available athttp://chpexpresseis.org.DOE will address these comments, to the extent they are still relevant, as well as those submitted during the public comment period for this Amended NOI, in the CHPE EIS.

Public Scoping for the Revised Applicant Proposal

Pursuant to the submittal of the Joint Proposal, the NY State Public Service Commission is holding six public statement hearings in April 2012 in a variety of locations along the revised Champlain Hudson project route, including the municipalities of Whitehall, Catskill, Ravena, Schenectady, Garnerville, and Astoria, NY. While DOE does not currently intend to hold further public scoping meetings, it recognizes that comments provided by the public during the Commission's public statement hearings may be relevant to DOE's NEPA process. Therefore, DOE intends to review the April public statement hearing transcripts, in addition to scoping comments submitted directly to DOE, and will consider them, to the extent matters relevant to the federal environmental review process arise, as scoping comments for purposes of the EIS.

Agency Purpose and Need, Proposed Action, and Alternatives

The purpose and need for DOE's action is to decide whether to grant a Presidential permit for the Champlain Hudson project.

The proposed Federal action is the granting of the Presidential permit for the construction, operation, maintenance, and connection of the proposed new electric transmission line across the U.S.-Canada border in northeastern New York State. The EIS will analyze potential environmental impacts from the proposed action and the No Action Alternative. Because the proposed action may involve actions in floodplains and wetlands, and in accordance with 10 CFR part 1022,Compliance with Floodplain and Wetland Environmental Review Requirements,the draft EIS will include a floodplain and wetland assessment as appropriate, and the final EIS or record of decision will include a floodplain statement of findings. If granted, the Presidential permit would authorize only that portion of the line that would be constructed, operated and maintained wholly within the U.S.

DOE is seeking comment on the scope of the alternatives proposed and potential environmental impacts for analyses in the EIS and currently proposes to analyze the following alternatives in detail: (1) the Champlain Hudson project, as proposed by the Applicant in the Joint Proposal filed with the New York Public Service Commission on February 24, 2012 and submitted to DOE on February 28, 2012 as an amended application for a Presidential permit, and (2) the No Action Alternative, which assumes that DOE would not grant a Presidential permit for the Champlain Hudson project and that the proposed line and associated facilities would not be constructed.

This notice announces EPA's approval of the State of Florida's requestto revise/modify certain of its EPA-authorized programs to allow electronic reporting.

DATES:

EPA's approval is effective May 30, 2012 for the State of Florida's National Primary Drinking Water Regulations Implementation program, if no timely request for a public hearing is received and accepted by the Agency, and on April 30, 2012 for the State of Florida's other authorized programs.

On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in theFederal Register(70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the State, Tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the State, Tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.

On February 22, 2011, the Florida Department of Environmental Protection (FDEP) submitted an application titled “e-Reporting System Electronic Document Receiving System” for revisions/modifications of its EPA-authorized programs under title 40 CFR. EPA reviewed FDEP's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Florida's request to modify/revise its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 51, 60, 70, 141, 144, 146, 257-258, 262-265, 268, and 270-271 is being published in theFederal Register:

Part 147—State, Tribal, and EPA-Administered Underground Injection Control Programs; and

Part 272—Approved State Hazardous Waste Management Programs.

FDEP was notified of EPA's determination to approve its application with respect to the authorized program listed above.

Also, in today's notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of Florida's request to revise its authorized public water system program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f). Requests for a hearing must be submitted to EPA within 30 days of publication of today'sFederal Registernotice. Such requests should include the following information:

(1) The name, address and telephone number of the individual, organization or other entity requesting a hearing;

(2) A brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request;

(3) The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.

In the event a hearing is requested and granted, EPA will provide notice of the hearing in theFederal Registernot less than 15 days prior to the scheduled hearing date. Frivolous or insubstantial requests for hearing may be denied by EPA. Following such a public hearing, EPA will review the record of the hearing and issue an order either affirming today's determination or rescinding such determination. If no timely request for a hearing is received and granted, EPA's approval of the State of Florida's request to revise its Part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting will become effective 30 days after today's notice is published, pursuant to CROMERR section 3.1000(f)(4).

The Environmental Protection Agency (EPA) receives from time to time Freedom of Information Act (FOIA) requests for documentation received or issued by EPA or data contained in EPA database systems pertaining to the export and import of Resource Conservation and Recovery Act (RCRA) hazardous waste from/to the United States, the export of cathode ray tubes (CRTs) and spent lead acid batteries (SLABs) from the United States, and the export and import of RCRA universal waste from/to the United States. These documents and data may identify or reference multiple parties, and describe transactions involving the movement of specified materials in which the parties propose to participate or have participated. The purpose of this notice is to inform “affected businesses” about the documents or data sought by these types of FOIA requests in order to provide the businesses with the opportunity to assert claims that any of the information sought that pertains tothem is entitled to treatment as confidential business information (CBI), and to send comments to EPA supporting their claims for such treatment. Certain businesses, however, do not meet the definition of “affected business,” and are not covered by today's notice. They consist of any business that actually submitted to EPA any document at issue pursuant to applicable RCRA regulatory requirements and did not assert a CBI claim as to information that pertains to that business in connection with the document at the time of its submission; they have waived their right to do so at a later time. Nevertheless, other businesses identified or referenced in the documents that were submitted to EPA by the submitting business may have a right to assert a CBI claim concerning information that pertains to them and may do so in response to this notice.

DATES:

Comments must be received on or before May 30, 2012. The period for submission of comments may be extended if, before the comments are due, you make a request for an extension of the comment period and it is approved by the EPA legal office. Except in extraordinary circumstances, the EPA legal office will not approve such an extension without the consent of any person whose request for release of the information under the FOIA is pending.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-HQ-OECA-2012-0331, by one of the following methods:

Instructions:Direct your comments to Docket ID No. EPA-HQ-OECA-2012-0331. EPA's policy is that all comments received will be included in the public docket without change and may be made available online athttp://www.regulations.gov,including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected throughhttp://www.regulations.govor email. Instructions about how to submit comments claimed as CBI are given later in this notice.

Thehttp://www.regulations.govWeb site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going throughhttp://www.regulations.gov,your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment. Please include your name and other contact information with any disk or CD-ROM you submit by mail. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage athttp://www.epa.gov/epahome/dockets.htm.

Docket:All documents in the docket are listed in thehttp://www.regulations.govindex.

Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically inhttp://www.regulations.govor in hard copy at the HQ EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the docket for this notice is (202) 566-1752.

Today's notice relates to any documents or data in the following areas: (1) Export of Resource Conservation and Recovery Act (RCRA) hazardous waste, during calendar year 2011 or before, under 40 CFR part 262, subparts E and H; (2) import of RCRA hazardous waste, during calendar year 2011 or before, under 40 CFR part 262, subparts F and H; (3) transit of RCRA hazardous waste, during calendar year 2011 or before, under 40 CFR part 262, subpart H, through the United States and foreign countries; (4) export of cathode ray tubes, during calendar year 2011 or before, under 40 CFR part 261, subpart E; (5) exports of non-crushed spent lead acid batteries with intact casings, during calendar year 2011 or before, under 40 CFR part 266 subpart G; (6) export and import of RCRA universal waste, during calendar year 2011 or before, under 40 CFR part 273, subparts B, C, D, and F; (7) submissions from transporters, during calendar year 2011 or before, under 40 CFR part 263, or from treatment, storage or disposal facilities under 40 CFR parts 264 and 265, related to exports or imports of hazardous waste which occurred during calendar year 2011 or before, including receiving facility notices under 40 CFR 264.12(a)(1) and 265.12(a)(1) and import consent documentation under 40 CFR 264.71(a)3) and 265.71(a)(3).

I. General Information

EPA has previously published notices similar to this one in theFederal Register, the latest one being at 76 FR 362, January 4, 2011 that address issues similar to those raised by today's notice. The Agency did not receive any comments on the previous notices. Since the publication of the January 3, 2012 notice, the Agency has continued to receive FOIA requests for documents and data contained in EPAs database related to hazardous waste exports and imports.

II. Issues Covered by This Notice

Specifically, EPA receives FOIA requests from time to time for documentation or data related to hazardous waste exports and imports that may identify or reference multiple parties, and that describe transactions involving the movement of specified materials in which the parties propose to participate or have participated. This notice informs “affected businesses,”1which could include, among others, “transporters”2and “consignees,”3ofthe requests for information in EPA database systems and/or contained in one or more of the following documents: (1) Documents related to the export of Resource Conservation and Recovery Act (RCRA) hazardous waste, during calendar year 2011 or before, under 40 CFR part 262, subparts E and H, including but not limited to the “notification of intent to export,”4“manifests,”5“annual reports,”6“EPA acknowledgements of consent,”7“any subsequent communication withdrawing a prior consent or objection,”8“responses that neither consent nor object,” “exception reports,”9“transit notifications,”10and “renotifications;”11(2) documents related to the import of hazardous waste, during calendar year 2011 or before, under 40 CFR part 262, subparts F and H, including but not limited to notifications of intent to import hazardous waste into the U.S. from foreign countries; (3) documents related to the transit of hazardous waste, during calendar year 2011 or before, under 40 CFR part 262, subpart H, including notifications from U.S. exporters of intent to transit through foreign countries, or notifications from foreign countries of intent to transit through the U.S.; (4) documents related to the export of cathode ray tubes (CRTs), during calendar year 2011 or before, under 40 CFR part 261, subpart E, including but not limited to notifications of intent to export CRTs; (5) documents related to the export of non-crushed spent lead acid batteries (SLABs) with intact casings, during calendar year 2011 or before, under 40 CFR part 266 subpart G, including but not limited to notifications of intent to export SLABs; (6) submissions from transporters under 40 CFR part 263, or from treatment, storage or disposal facilities under 40 CFR parts 264 and 265, related to exports or imports of hazardous waste which occurred during calendar year 2011 or before, including receiving facility notices under 40 CFR 264.12(a)(1) and 265.12(a)(1) and import consent documentation under 40 CFR 264.71(a)(3) and 265.71(a)(3), and (7) documents related to the export and import of RCRA “universal waste”12under 40 CFR part 273, subparts B, C, D, and F.

1The term “affected business” is defined at 40 CFR 2.201(d), and is set forth in this notice, below.

2The term “transporter” is defined at 40 CFR 260.10.

3The term “consignee” is defined, for different purposes, at 40 CFR 262.51 and 262.81(c).

4The term “notification of intent to export” is described at 40 CFR 262.53.

5The term “manifest” is defined at 40 CFR 260.10.

6The term “annual reports” is described at 40 CFR 262.56.

7The term “EPA acknowledgement of consent” is defined at 40 CFR 262.51.

8The requirement to forward to the exporter “any subsequent communication withdrawing a prior consent or objection” is found at 42 U.S.C. 6938(e).

9The term “exception reports” is described at 40 CFR 262.55.

10The term “transit notifications” is described at 40 CFR 262.53(e).

11The term “renotifications” is described at 40 CFR 262.53(c).

12The term “universal waste” is defined at 40 CFR 273.9.

Certain businesses, however, do not meet the definition of “affected business,” and are not covered by today's notice. They consist of any business that actually submitted information responsive to a FOIA request, under the authority of 40 CFR parts 260 through 266 and 268, and did not assert a claim of business confidentiality covering any of that information at the time of submission. As set forth in the RCRA regulations at 40 CFR 260.2(b), “if no such [business confidentiality] claim accompanies the information when it is received by EPA, it may be made available to the public without further notice to the person submitting it.” Thus, for purposes of this notice and as a general matter under 40 CFR 260.2(b), a business that submitted to EPA the documents at issue, pursuant to applicable regulatory requirements, and that failed to assert a claim as to information that pertains to it at the time of submission, cannot later make a business confidentiality claim.13Nevertheless, other businesses identified or referenced in the same documents that were submitted to EPA by the submitting business may have a right to assert a CBI claim concerning information that pertains to them and may do so in response to this notice.

13However, businesses having submitted information to EPA relating to the export and import of RCRA universal waste are not subject to 40 CFR 260.2(b) since they submitted information in accordance with 40 CFR part 273, and not parts 260 through 266 and 268, as set forth in 40 CFR 260.2(b). They are therefore affected businesses that could make a claim of CBI at the time of submission or in response to this notice.

In addition, EPA may develop its own documents and organize into its database systems information that was originally contained in documents from submitting businesses relating to exports and imports of hazardous waste. If a submitting business fails to assert a CBI claim for the documents it submits to EPA at the time of submission, not only does it waive its right to claim CBI for those documents, but it also waives its right to claim CBI for information in EPA's documents or databases that is based on or derived from the documents that were originally submitted by that business.14

14With the exception, noted above, of the submission of information relating to the export and import of RCRA universal waste.

In accordance with 40 CFR 2.204(c) and (e), this notice inquires whether any affected business asserts a claim that any of the requested information constitutes CBI, and affords such business an opportunity to comment to EPA on the issue. This notice also informs affected businesses that, if a claim is made, EPA would determine under 40 CFR part 2, subpart B, whether any of the requested information is entitled to business confidential treatment.

1. Affected Businesses

EPA's FOIA regulations at 40 CFR 2.204(c)(1) require an EPA office that is responsible for responding to a FOIA request for the release of business information (“EPA office”) “to determine which businesses,if any, are affected businesses * * *.” “Affected business” is defined at 40 CFR 2.201(d) as, “* * * with reference to an item of business information, a business which has asserted (and not waived or withdrawn) a business confidentiality claim covering the information, or a business which could be expected to make such a claim if it were aware that disclosure of the information to the public was proposed.”

2. The Purposes of This Notice

This notice encompasses two distinct steps in the process of communication with affected businesses prior to EPA's making a final determination concerning the business confidentiality of the information at issue: the preliminary inquiry and the notice of opportunity to comment.

a. Inquiry To Learn Whether Affected Businesses (Other Than Those Businesses That Previously Asserted a CBI Claim) Assert Claims Covering Any of the Requested Information

Section 2.204(c)(2)(i) provides, in relevant part:

If the examination conducted under paragraph (c)(1) of this section discloses the existence of any business which, although it has not asserted a claim, might be expected to assert a claim if it knew EPA proposed to disclose the information, the EPA office shall contact a responsible official of each such business to learn whether the business asserts a claim covering the information.

b. Notice of Opportunity To Submit Comments

Sections 2.204(d)(1)(i) and 2.204(e)(1) of Title 40 of the Code of Federal Regulations require that written notice be provided to businesses that have made claims of business confidentiality for any of the information at issue,stating that EPA is determining under 40 CFR part 2, subpart B, whether the information is entitled to business confidential treatment, and affording each business an opportunity to comment as to the reasons why it believes that the information deserves business confidential treatment.

3. The Use of Publication in the Federal Register

Section 2.204(e)(1) of Title 40 of the Code of Federal Regulations requires that this type of notice be furnished by certified mail (return receipt requested), by personal delivery, or by other means which allows verification of the fact and date of receipt. EPA, however, has determined that in the present circumstances the use of aFederal Registernotice is the only practical and efficient way to contact affected businesses and to furnish the notice of opportunity to submit comments. The Agency's decision to follow this course was made in recognition of the administrative difficulty and impracticality of directly contacting potentially thousands of individual businesses.

4. Submission of Your Response in the English Language

All responses to this notice must be in the English language.

5. The Effect of Failure To Respond to This Notice

In accordance with 40 CFR 2.204(e)(1) and 2.205(d)(1), EPA will construe your failure to furnish timely comments in response to this notice as a waiver of your business's claim(s) of business confidentiality for any information in the types of documents identified in this notice.

6. What To Include in Your Comments

If you believe that any of the information contained in the types of documents which are described in this notice and which are currently, or may become, subject to FOIA requests, is entitled to business confidential treatment, please specify which portions of the information you consider business confidential. Information not specifically identified as subject to a business confidentiality claim may be disclosed to the requestor without further notice to you.

For each item or class of information that you identify as being subject to your claim, please answer the following questions, giving as much detail as possible:

1. For what period of time do you request that the information be maintained as business confidential, e.g., until a certain date, until the occurrence of a specified event, or permanently? If the occurrence of a specific event will eliminate the need for business confidentiality, please specify that event.

2. Information submitted to EPA becomes stale over time. Why should the information you claim as business confidential be protected for the time period specified in your answer to question no. 1?

3. What measures have you taken to protect the information claimed as business confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information still be considered business confidential?

4. Is the information contained in any publicly available material such as the Internet, publicly available data bases, promotional publications, annual reports, or articles? Is there any means by which a member of the public could obtain access to the information? Is the information of a kind that you would customarily not release to the public?

5. Has any governmental body made a determination as to the business confidentiality of the information? If so, please attach a copy of the determination.

6. For each category of information claimed as business confidential, explain with specificity why release of the information is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?

7. Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for your assertion. If the business asserts that the information is voluntarily submitted information, please explain whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.

8. Any other issue you deem relevant.

Please note that you bear the burden of substantiating your business confidentiality claim. Conclusory allegations will be given little or no weight in the determination. If you wish to claim any of the information in your response as business confidential, you must mark the response “BUSINESS CONFIDENTIAL” or with a similar designation, and must bracket all text so claimed. Information so designated will be disclosed by EPA only to the extent allowed by, and by means of, the procedures set forth in, 40 CFR part 2, subpart B. If you fail to claim the information as business confidential, it may be made available to the requestor without further notice to you.

III. What should I consider as I prepare my comments for EPA?

1.Submitting CBI.Do not submit this information to EPA throughhttp://www.regulations.govor email. Please submit this information by mail to the address identified in theADDRESSESsection of today's notice for inclusion in the non-public CBI docket. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. Information so marked will not be disclosed except in accordance with the procedures set forth in 40 CFR part 2, subpart B. In addition to the submission of one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket.

The EPA Science Advisory Board (SAB) Staff Office announces a public meeting of the SAB Exposure and Human Health Committee to develop a work plan for advancing the EPA's application of Computational Toxicology (CompTox) data into the development of EPA hazard and risk assessments.

DATES:

The meeting will be held on Wednesday, May 30, 2012 from 10:00 a.m. to 5:00 p.m. (Eastern Time) and Thursday, May 31, 2012 from 8:30 a.m. to 12:30 p.m. (Eastern Time).

ADDRESSES:

The public meeting will be held at The Embassy Row Hotel, 2015 Massachusetts Ave. NW., Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT:

Any member of the public who wants further information concerning the public meeting may contact Dr. Sue Shallal, Designated Federal Officer (DFO), via telephone at (202) 564-2057 or email atshallal.suhair@epa.gov.General information concerning the SAB can be found on the EPA Web site athttp://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION:

The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act, codified at 42 U.S.C. 4365 to provide independent scientific and technical advice to the EPA Administrator on the technical basis for EPA actions. The SAB is undertaking an initiative to develop advice to assist EPA in advancing the application of ORD's Computational CompTox research for human health risk assessment to meet its programmatic needs. ORD's CompTox Research Program conducts innovative research that integrates advances in molecular biology, chemistry and innovative computer science to more effectively and efficiently rank chemicals based on risks. The goal of the CompTox Research Program is to provide high-throughput chemical screening data and decision support tools for assessing chemical exposure, hazard, and risk to human health and the environment. Pursuant to Federal Advisory Committee Act (FACA) and EPA policy, notice is hereby given that the SAB Exposure and Human Health Committee, along with liaison members from the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), will hold a public meeting to receive briefings from EPA offices and develop a work plan for this advisory activity. The SAB Exposure and Human Health Committee will provide advice through the chartered SAB and will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies.

Availability of Meeting Materials:Prior to the meeting, the review documents, agenda and other materials will be accessible through the calendar link on the blue navigation bar athttp://www.epa.gov/sab/.

Procedures for Providing Public Input:Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office. Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Interested members of the public may submit relevant written or oral information on the topic of this advisory activity, and/or the group conducting the activity, for the SAB to consider during the advisory process. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for SAB committees to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the DFO directly.Oral Statements:In general, individuals or groups requesting an oral presentation at a public meeting will be limited to five minutes. Interested parties should contact Dr. Sue Shallal, DFO, in writing (preferably via email) at the contact information noted above by May 23, 2012, to be placed on the list of public speakers for the meeting.Written Statements:Written statements should be supplied to the DFO via email at the contact information noted above by May 23, 2012 for the meeting so that the information may be made available to the Committee members for their consideration. Written statements should be supplied in one of the following electronic formats: Adobe Acrobat PDF, MS Word, MS PowerPoint, or Rich Text files in IBM-PC/Windows 98/2000/XP format. It is the SAB Staff Office general policy to post written comments on the Web page for the advisory meeting or teleconference. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the SAB Web site. Copyrighted material will not be posted without explicit permission of the copyright holder.

Accessibility:For information on access or services for individuals with disabilities, please contact Dr. Sue Shallal at (202) 564-2057 orshallal.suhair@epa.gov.To request accommodation of a disability, please contact Dr. Shallal preferably at least ten days prior to the meeting to give EPA as much time as possible to process your request.

The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of an existing information collection, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). Currently, the FDIC is soliciting comment on renewal of the information collection described below.

DATES:

Comments must be submitted on or before June 29, 2012.

ADDRESSES:

Interested parties are invited to submit written comments to the FDIC by any of the following methods:

•http://www.FDIC.gov/regulations/laws/federal/notices.html.

•Email: comments@fdic.govInclude the name of the collection in the subject line of the message.

•Hand Delivery:Comments may be hand-delivered to the guard station at the rear of the 17th Street Building (located on F Street), on business days between 7:00 a.m. and 5:00 p.m.

All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Gary A. Kuiper, at the FDIC address above.

SUPPLEMENTARY INFORMATION:Proposal To Renew the Following Currently-Approved Collection of Information

Title:Notice Regarding Assessment Credits.

OMB Number:3064-0151.

Frequency of Response:On occasion.

Affected Public:FDIC-insured institutions.

Estimated Number of Respondents:4.

Estimated Time per Response:2 hours.

Estimated Total Annual Burden:8 hours.

General Description of Collection:FDIC-insured institutions must notify the FDIC if deposit insurance assessment credits are transferred, e.g., through a sale of the credits or through a merger, in order to obtain recognition of the transfer.

Request for Comment

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

Dated at Washington, DC, this 25th day of April 2012.Federal Deposit Insurance Corporation.Robert E. Feldman,Executive Secretary.[FR Doc. 2012-10347 Filed 4-27-12; 8:45 am]BILLING CODE PFEDERAL DEPOSIT INSURANCE CORPORATIONUpdate to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or ManagerAGENCY:

Federal Deposit Insurance Corporation.

ACTION:

Update Listing of Financial Institutions in Liquidation.

SUMMARY:

Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in theFederal Register) may be relied upon as “of record” notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992 issue of theFederal Register(57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site atwww.fdic.gov/bank/individual/failed/banklist.htmlor contact the Manager of Receivership Oversight in the appropriate service center.

The companies listed in this notice have applied to the Board for approval, pursuant to Section 25A of the Federal Reserve Act (Edge Corporation) 12 U.S.C. Sec. 611et seq.,and all other applicable statutes and regulations to establish an Edge Corporation. The Edge Corporation will operate as a subsidiary of the applicant, Lake Forest Bank and Trust Company, Lake Forest, Illinois. The factors that are to be considered in acting on the application are set forth in the Board's Regulation K (12 CFR 211.4).

The applications below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in Section 25 of the Federal Reserve Act.

Unless otherwise noted, comments regarding each of these applications may be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 15, 2012.

Notice of request for comments regarding a reinstatement to an existing OMB clearance.

SUMMARY:

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding the Civilian Board of Contract Appeals (CBCA) Rules of Procedure. A notice was published in theFederal Registerat 77 FR 5020, on February 1, 2012. No comments were received.

Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.

DATES:

Submit comments on or before: May 30, 2012.

Submit comments identified by Information Collection IC 3090-0221, Civilian Board of Contract Appeals Rules of Procedure, by any of the following methods:

•Regulations.gov: http://www.regulations.gov.Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection IC 3090-0221, Civilian Board of Contract Appeals Rules of Procedure”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 3090-0221, Civilian Board of Contract Appeals Rules of Procedure” on your attached document.

Instructions:Please submit comments only and cite Information Collection 3090-0221, Civilian Board of Contract Appeals Rules of Procedure, in all correspondence related to this collection. All comments received will be posted without change tohttp://www.regulations.gov,including any personal and/or business confidential information provided.

The CBCA requires the information collected in order to conduct proceedings in contract appeals and petitions, and cost applications. Parties include those persons or entities filing appeals, petitions, cost applications, and government agencies.

Notice of request for public comments regarding an extension to an existing OMB clearance.

SUMMARY:

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding solicitation provisions and contract clauses, placement of orders clause, and ordering information clause. A notice was published in theFederal Registerat 77 FR 3476, on January 24, 2012. No comments were received.

Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected.

Instructions:Please submit comments only and cite Information Collection 3090-0248, GSAR 516-506, Solicitation Provisions and Contract Clauses; 552.216-72, Placement of Orders Clause, and 552.216-73, Ordering Information Clause, in all correspondence related to this collection. All comments received will be posted without change tohttp://www.regulations.gov,including any personal and/or business confidential information provided.

SUPPLEMENTARY INFORMATION:A. Purpose

The General Services Administration (GSA) has various mission responsibilities related to the acquisition and provision of the Federal Acquisition Service's (FAS's) Stock, Special Order, and Schedules Programs. These mission responsibilities generate requirements that are realized through the solicitation and award of various types of FAS contracts. Individual solicitations and resulting contracts may impose unique information collection and reporting requirements on contractors, not required by regulation, but necessary to evaluate particular program accomplishments and measure success in meeting program objectives. As such, GSAR 516.506, Solicitation provision and clauses, specifically directs contracting officers to insert 552.216-72, Placement of Orders, when the contract authorizes FAS and other activities to issue delivery or task orders and 552.216-73, Ordering Information, directs the Offeror to elect to receive orders placed by FAS by either facsimile transmission or computer-to-computer Electronic Data Interchange (EDI).

Department of Health and Human Services, Office of the Secretary, Officeof the Assistant Secretary for Health.

ACTION:

Notice.

SUMMARY:

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.

DATES:

The meeting will be held Wednesday, May 16, 2012 and Thursday, May 17, 2012. The meeting will be held from 9:00 a.m. to approximately 5:00 p.m. on Wednesday, May 16, 2012 and 9:00 a.m. to approximately 5:00 p.m. on Thursday, May 17, 2012.

PACHA was established by Executive Order 12963, dated June 14, 1995 as amended by Executive Order 13009, dated June 14, 1996. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention of HIV disease and AIDS. The functions of the Council are solely advisory in nature.

The Council consists of not more than 25 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. Council members are appointed by the Secretary or designee, in consultation with the White House Office on National AIDS Policy. The agenda for the upcoming meeting will be posted on the Council's Web site atwww.aids.gov/pacha.

Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Pre-registration for public attendance is advisable and can be accomplished by contacting the PACHA Committee Manager atmelvin.joppy@hhs.gov.

Members of the public will have the opportunity to provide comments at the meeting. Any individual who wishes to participate in the public comment session must register with Melvin Joppy atmelvin.joppy@hhs.gov;registration for public comment will not be accepted by telephone. Public comment will be limited to two minutes per speaker. Any members of the public who wish to have printed material distributed to PACHA members at the meeting should submit, at a minimum, 1 copy of the materials to the Committee Manager, PACHA, no later than close of business Wednesday, May 9, 2012. Contact information for the PACHA Committee Manager is listed above.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects.

To request more information on the proposed projects or to obtain a copy ofthe data collection plans and instruments, call 404-639-7570 and send comments to Kimberly S. Lane, at CDC, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email toomb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

The STD Surveillance Network (SSuN) project is an active STD sentinel surveillance network comprised of 12 surveillance sites including Alabama State Health Department, Baltimore City Health Department, Chicago City Health Department, Colorado State Health Department, Connecticut State Health Department, Los Angeles City Health Department, Louisiana State Health Department, New York City Health Department, Philadelphia city Health Department, San Francisco City Health Department, Virginia State Health Department, Washington State Health Department. The objectives of the SSuN Project are (1) to establish an integrated network of sentinel STD clinics and health departments to inform and guide national programs and policies for STD control in the U.S.; (2) to improve the capacity of national, state and local STD programs to detect, monitor and respond to established and emerging trends in STDs, HIV, and viral hepatitis; and (3) to identify and evaluate the effectiveness of public health interventions to reduce STD morbidity. This project collects data using two surveillance strategies; enhanced surveillance in participating STD clinics and enhanced gonorrhea surveillance on a random sample of persons diagnosed with gonorrhea in participating jurisdictions of these 12 local and state health departments.

For the clinic-based surveillance, participating sites have developed common protocols stipulating which data elements would be collected, including demographic, clinical, risk and sexual behaviors. The specified data elements are abstracted on a quarterly basis from existing electronic medical records for all patient visits to participating clinics and transmitted to CDC through a secured channel. Each SSuN site will spend 2 hours to transmit the data to CDC each quarter. At CDC, data will be aggregated with data from all participating sites in a common language and formatted for analysis.

For the population-based surveillance, a random sample of individuals reported with gonorrhea residing within participating jurisdictions are interviewed using locally designed interview templates. Enhanced data collection includes detailed information on demographic characteristics, behavioral risk factors and clinical history of persons with gonorrhea. Each of the 12 sites will interview 60 persons each quarter and each interview is expected to take about 8 minutes per person. Data for the population-based component will continue to be collected through telephone-administered or in-person interviews conducted by trained interviewers in the 12 SSuN sites. The survey results will be entered into the existing information systems at each health department and sent to CDC through a secure data network on a quarterly basis.

This information is being collected to establish (1) an integrated network of sentinel STD clinics and (2) state and local health departments to inform and guide national programs and policies for STD control in the US.

The Centers for Disease Control and Prevention request approval for a revision and a 3 year approval for the previously approved STD Surveillance Network (SSuN) project 0920-0842 (exp. 1/31/2013). The interview template has been revised to include four additional questions related to insurance status, but these changes will have minimal effect on the burden per respondent. Information on insurance and health care access are expected to have implications for program at the state/local and national level and can be used by state and local programs. Otherwise, the project activities and methods will remain the same as those used in the previously approved data collection period.

Participation of respondents is voluntary. There is no cost to the respondents other than their time.

There is no cost to the respondents other than their time.

RespondentNumber of

respondents

Number of

responses per respondent

Average

burden per

response

(in hours)

Total burden

(in hours)

STD Surveillance Clinics124296Gonorrhea patients288018/60384Total480Kimberly S. Lane,Deputy Director, Office of Science Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.[FR Doc. 2012-10325 Filed 4-27-12; 8:45 am]BILLING CODE 4163-18-PDEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention[60Day-12-12IN]Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call (404) 639-7570 and send comments to Kimberly S. Lane, at CDC, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email toomb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

Developing a Responsive Plan for Building the Capacity of Community Based Organizations (CBOs) to Implement HIV Prevention Services—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) estimates that over 1 million people in the United States are living with HIV. Each year, approximately 50,000 people in the United States become newly infected. Some groups are disproportionately affected by this epidemic. For example, between 2006 and 2009, there was an almost 50% increase in the number of new HIV infections among young Black men who have sex with men (MSM). In order to address these health disparities, the CDC funded 34 community-based organizations via cooperative agreement PS11-1113 to implement HIV prevention programs targeting young MSM of color and young transgender persons of color.

Building the capacity of community based organizations (CBOs) is a priority to ensure effective and efficient delivery of HIV prevention services. Since the late 1980s, CDC has been working with CBOs to broaden the reach of HIV prevention efforts. Over time, the CDC's program for HIV prevention has grown in size, scope, and complexity, responding to changes in approaches to addressing the epidemic, including the introduction of new guidances; effective behavioral, biomedical, and structural interventions; and public health strategies. The Capacity Building Branch within the Division of HIV/AIDS Prevention (D provides national leadership and support for capacity building assistance (CBA) to help improve the performance of the HIV prevention workforce. One way that it accomplishes this task is by funding CBA providers via cooperative agreement PS09-906 to work with CBOS, health departments, and communities to increase their knowledge, skills, technology, and infrastructure to implement and sustain science-based, culturally appropriate interventions and public health strategies.

CBA providers will conduct face-to-face field visits with the CBOs utilizing a structured organizational needs assessment tool that was developed in collaboration with CDC. This comprehensive tool offers a mixed-methods data collection approach consisting of checklists, close-ended (quantitative) questions, and open-ended (qualitative) questions. CBOs will be asked to complete the tool prior to the field visits in order to maximize time during the visits for discussion and strategic planning.

Findings from this project will be used by the participating CBOs, the CBA providers, and the Capacity Building Branch. By the end of the project, the participating CBOs will have tailored CBA strategic plans that they can use to help sustain their programs across and beyond the life of their five-year cooperative agreements. Based on these plans, the CBA providers (in collaboration with CDC) will be able to better identify and address those needs most reported by CBOs. Finally, the Capacity Building Branch will be able to refine its approach to conceptualizing and providing CBA on a national level in the most cost-effective manner possible.

There is no cost to respondents other than their time. The CBA providers will complete their field visits in one day (8 hours). Eighteen of the participating CBOs are dually funded under both PS11-1113 and PS10-1003; they participated in a similar process under the earlier cooperative agreement. Therefore, they will not need to complete the full tool nor participate in a full-day field visit; the burden will be reduced for these respondents.

CBOs only funded under PS11-1113CBO/CBA Needs Assessment161348Dually funded CBOs (funded under both PS11-1113 and PS10-1003)CBO/CBA Needs Assessment1811.527Total75Kimberly S. Lane,Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.[FR Doc. 2012-10324 Filed 4-27-12; 8:45 am]BILLING CODE 4163-18-PDEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and PreventionDisease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

Status:The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463.

Matters to be Discussed:The meeting will include the initial review, discussion, and evaluation of applications received in response to “Research Grants for Preventing Violence and Violence Related Injury, FOA CE12-002, initial review.”

The Director, Management Analysis and Services Office, has been delegated the authority to signFederal Registernotices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Description:Federal statute and regulation require each State Protection and Advocacy (P&A) System to prepare and submit to public comment a Statement of Goals and Priorities (SGP) for the P&A for Developmental Disabilities (PADD) program for each coming fiscal year. While the P&A is mandated to protect and advocate under a range of different Federally authorized disabilities programs, only the PADD program requires an SGP. Following the required public input for the coming fiscal year, the P&As submit the final version of this SGP to the Administration on Developmental Disabilities (ADD). ADD will aggregate the information in the SGPs into a national profile of programmatic emphasis for P&A Systems in the coming year. This aggregation will provide ADD with a tool for monitoring of the public input requirement. Furthermore, it will provide an overview of program direction, and permit ADD to track accomplishments against goals/targets, permitting the formulation of technical assistance and compliance with the Government Performance and Results Act of 1993.

Respondents:State and Territory Protection and Advocacy Systems.

Annual Burden EstimatesInstrumentNumber of

respondents

Number of

responses per respondent

Average

burden hours per response

Total burden hoursP&A SGP571442,508

Estimated Total Annual Burden Hours:2,508.

In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address:infocollection@acf.hhs.gov.All requests should be identified by the title of the information collection.

The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden information to be collected; and (e) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Description:This information collection is required by federal statute. Each State Protection and Advocacy System must prepare and submit a program Performance Report for the preceding fiscal year of activities and accomplishments and of conditions in the State. The information in the Annual Report will be aggregated into a national profile of Protection and Advocacy Systems. It will also provide the Administration on Developmental Disabilities (ADD) with an overview of program trends and achievements and will enable ADD to respond to administration and congressional requests for specific information on program activities. This information will also be used to submit a Centennial Report to Congress as well as to comply with requirements in the Government Performance and Results Act of 1993.

Respondents:Protection & Advocacy Systems.

Annual Burden EstimatesInstrumentNumber of

respondents

Number of

responses per respondent

Average

burden hours per response

Total burden hoursDevelopmental Disabilities Protection and Advocacy Program Performance Report571442,508

Estimated Total Annual Burden Hours:2,508:

Additional Information:Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address:infocollection@acf.hhs.gov.

OMB Comment:OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in theFederal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202-395-7285, Email:OIRA_SUBMISSION@OMB.EOP.GOV.Attn: Desk Officer for the Administration for Children and Families.

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee:Center for Scientific Review Special Emphasis Panel; Lung Fibrosis Conflict Applications.

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee:National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; MSM Program Review.